DOCSLIB.ORG

Answers to Problems

Total Page：16

File Type：pdf, Size：1020Kb

Download full-text PDF Read full-text
Answers to Problems ANSWERS TO PROBLEMS Chapter 1 8. There are 20 choices for each of the 50 amino acids: 5020, or 21 1. The hydrogen-bond donors are the NH and NH2 groups. 5 3 10 . The hydrogen-bond acceptors are the carbonyl oxygen atoms and 9. those ring nitrogen atoms that are not bonded to hydrogen or to O O deoxyribose. + 2. Interchange the positions of the single and double bonds in the H3N CH C N CH C O CH3 six-membered ring. 3. (a) Electrostatic interactions; (b) van der Waals interactions. CH2 H CH2 4. Processes a and b C O 2 2 2 2 5. DS 5 2661 J mol 1 K 1 (2158 kcal mol 1 K 1) system O 21 21 21 21 DSsurroundings 5 1842 J mol K (1201 cal mol K ) 6. (a) 1.0; (b) 13.0; (c) 1.3; (d) 12.7 7. 2.88 Aspartame at pH 7 8. 1.96 10. The (nitrogen–a carbon–carbonyl carbon) repeating unit. 9. 11.83 11. Side chain is the functional group attached to the a-carbon 10. 447; 0.00050 atom of an amino acid. 11. 0.00066 M 12. Amino acid composition refers simply to the amino acids 12. 6.0 that make up the protein. The order is not specified. Amino acid 13. 5.53 sequence is the same as the primary structure—the sequence of 14. 6.48 amino acids from the amino terminal to the carboxyl terminal 15. 7.8 of the protein. Different proteins may have the same amino acid 16. 100 composition, but amino acid sequence identifies a unique protein. 17. (a) 1.6; (b) 0.51; (c) 0.16. 13. (a) Each strand is 35 kd and hence has about 318 residues (the 18. 0.1 M sodium acetate solution: 6.34; 6.03; 5.70; 4.75. mean residue mass is 110 daltons). Because the rise per residue in an 0.01 M sodium acetate solution: 5.90; 4.75; 3.38; 1.40. a helix is 1.5 Å, the length is 477 Å. More precisely, for an a-helical 19. 90 mM acetic acid; 160 mM sodium acetate, 0.18 moles acetic coiled coil, the rise per residue is 1.46 Å; so the length is 464 Å. acid; 0.32 moles sodium acetate; 10.81 g acetic acid; 26.25 g sodium (b) Eighteen residues in each strand (40 minus 4 divided by 2) are acetate. in a b-sheet conformation. Because the rise per residue is 3.5 Å, 20. 0.50 moles of acetic acid; 0.32 moles of NaOH; 30.03 g of acetic the length is 63 Å. acid; 12.80 g of NaOH. 14. The methyl group attached to the b-carbon atom of isoleucine 21. 250 mM; yes; no, it will also contain 90 mM NaCl. sterically interferes with a-helix formation. In leucine, this methyl g 22. 8.63 g Na2HPO4; 4.71 g NaH2PO4 group is attached to the -carbon atom, which is farther from the 23. 7.0; this buffer will not be very useful, because the pH value is main chain and hence does not interfere. far from the pKa value. 15. The first mutation destroys activity because valine occupies 2 2 2 2 24. 1.45 kJ mol 1 (0.35 kcal mol 1); 57.9 kJ mol 1 (13.8 kcal mol 1) more space than alanine does, and so the protein must take a dif- 25. There will be approximately 15 million differences. ferent shape, assuming that this residue lies in the closely packed interior. The second mutation restores activity because of a com- Chapter 2 pensatory reduction of volume; glycine is smaller than isoleucine. 1. (A) Proline, Pro, P; (B) tyrosine, Tyr, Y; (C) leucine, Leu, L; 16. The native conformation of insulin is not the thermodynami- (D) lysine, Lys, K. cally most stable form, because it contains two separate chains 2. (a) C, B, A; (b) D; (c) D, B; (d) B, D; (e) B. linked by disulfide bonds. Insulin is formed from proinsulin, a 3. (a) 6; (b) 2; (c) 3; (d) 1; (e) 4; (f ) 5. single-chain precursor, that is cleaved to form insulin, a 51-residue 4. (a) Ala; (b) Tyr; (c) Ser; (d) His. molecule, after the disulfide bonds have formed. 5. Ser, Glu, Tyr, Thr 17. A segment of the main chain of the protease could hydrogen 6. (a) Alanine-glycine-serine; (b) Alanine; (c and d): bond to the main chain of the substrate to form an extended paral- b Peptide bonds lel or antiparallel pair of strands. 18. Glycine has the smallest side chain of any amino acid. Its size CH3 HHO CH2OH is often critical in allowing polypeptide chains to make tight turns or to approach one another closely. N C C NCCNC C 19. Glutamate, aspartate, and the terminal carboxylate can form salt bridges with the guanidinium group of arginine. In addition, H H O H H H O this group can be a hydrogen-bond donor to the side chains of Alpha carbons glutamine, asparagine, serine, threonine, aspartate, tyrosine, and glutamate and to the main-chain carbonyl group. Histidine can 7. OO OOform hydrogen bonds with arginine at pH7. + – +– H3N CH C N CH C O H3N CH C N CH C O 20. Disulfide bonds in hair are broken by adding a thiol-containing HHCH HHCH reagent and applying gentle heat. The hair is curled, and an oxidiz- 2 2 ing agent is added to re-form disulfide bonds to stabilize the desired +HN N shape. 21. Some proteins that span biological membranes are “the excep- NH NH tions that prove the rule” because they have the reverse distribution At pH 5.5, the net charge is 11 At pH 7.5, the net charge is 0 of hydrophobic and hydrophilic amino acids. For example, consider A1 A2 ANSWERS TO PROBLEMS porins, proteins found in the outer membranes of many bacteria. 5. The sample was diluted 1000-fold. The concentration after Membranes are built largely of hydrophobic chains. Thus, porins dialysis is thus 0.001 M, or 1 mM. You could reduce the salt are covered on the outside largely with hydrophobic residues that concentration by dialyzing your sample, now 1 mM, in more interact with the neighboring hydrophobic chains. In contrast, the buffer free of (NH4)2SO4. center of the protein contains many charged and polar amino acids 6. If the salt concentration becomes too high, the salt ions interact that surround a water-filled channel running through the middle of with the water molecules. Eventually, there will not be enough the protein. Thus, because porins function in hydrophobic environ- water molecules to interact with the protein, and the protein will ments, they are “inside out” relative to proteins that function in precipitate. If there is lack of salt in a protein solution, the proteins aqueous solution. may interact with one another—the positive charges on one protein 22. The amino acids would be hydrophobic in nature. An a helix with the negative charges on another or several others. Such an is especially suited to crossing a membrane because all of the amide aggregate becomes too large to be solublized by water alone. If salt hydrogen atoms and carbonyl oxygen atoms of the peptide back- is added, the salt neutralizes the charges on the proteins, preventing bone take part in intrachain hydrogen bonds, thus stabilizing these protein–protein interactions. polar atoms in a hydrophobic environment. 7. Tropomyosin is rod shaped, whereas hemoglobin is approxi- 23. This example demonstrates that the pKa values are affected mately spherical. by the environment. A given amino acid can have a variety of pKa 8. The frictional coefficient, f, and the mass, m, determine s. values, depending on the chemical environment inside the protein. Specifically, f is proportional to r (see equation 2 on p. 71). Hence, 24. A possible explanation is that the severity of the symptoms f is proportional to m1/3, and so s is proportional to m2/3 (see the corresponds to the degree of structural disruption. Hence, substi- equation on p. 76). An 80-kd spherical protein undergoes sedi- tution of alanine for glycine might result in mild symptoms, but mentation 1.59 times as rapidly as a 40-kd spherical protein. substitution of the much larger tryptophan might prevent little or 9. The long hydrophobic tail on the SDS molecule (see p. 72) dis- no collagen triple-helix formation. rupts the hydrophobic interactions in the interior of the protein. 25. The energy barrier that must be crossed to go from the poly- The protein unfolds, with the hydrophobic R groups now interact- merized state to the hydrolyzed state is large even though the ing with SDS rather than with one another. reaction is thermodynamically favorable. 10. 50 kd. 26. Using the Henderson–Hasselbalch equation, we find the ratio 11. The protein may be modified. For instance, serine, threonine, 2 2 of alanine-COOH to alanine-COO at pH 7 to be 10 4. The ratio and tyrosine may have phosphoryl groups attached. 1 of alanine-NH2 to alanine-NH3 , determined in the same fashion, 12. A fluorescence-labeled derivative of a bacterial degradation 2 is 10 1. Thus, the ratio of neutral alanine to the zwitterionic species product (e.g., a formylmethionyl peptide) would bind to cells 2 2 2 is 10 4 3 10 1 5 10 5. containing the receptor of interest. 27. The assignment of absolute configuration requires the assign- 13.
Load more

Recommended publications
  • Methionine Synthase Supports Tumor Tetrahydrofolate Pools
    bioRxiv preprint doi: https://doi.org/10.1101/2020.09.05.284521; this version posted September 7, 2020. The copyright holder for this preprint (which was not certified by peer review) is the author/funder. All rights reserved. No reuse allowed without permission. Methionine synthase supports tumor tetrahydrofolate pools Joshua Z. Wang1,2,#, Jonathan M. Ghergurovich1,3,#, Lifeng Yang1,2, and Joshua D. Rabinowitz1,2,* 1 Lewis-Sigler Institute for Integrative Genomics, Princeton University, Princeton, New Jersey, USA 2 Department of Chemistry, Princeton University, Princeton, New Jersey, USA 3 Department of Molecular Biology, Princeton University, Princeton, New Jersey, USA # These authors contributed equally to this work. *Corresponding author: Joshua Rabinowitz Department of Chemistry and the Lewis-Sigler Institute for Integrative Genomics, Princeton University, Washington Rd, Princeton, NJ 08544, USA Phone: (609) 258-8985; e-mail: [email protected] Conflict of Interest Disclosure: J.D.R. is a paid advisor and stockholder in Kadmon Pharmaceuticals, L.E.A.F. Pharmaceuticals, and Rafael Pharmaceuticals; a paid consultant of Pfizer; a founder, director, and stockholder of Farber Partners and Serien Therapeutics. JDR and JMG are inventors of patents in the area of folate metabolism held by Princeton University. 1 bioRxiv preprint doi: https://doi.org/10.1101/2020.09.05.284521; this version posted September 7, 2020. The copyright holder for this preprint (which was not certified by peer review) is the author/funder. All rights reserved. No reuse allowed without permission. Abstract Mammalian cells require activated folates to generate nucleotides for growth and division. The most abundant circulating folate species is 5-methyl tetrahydrofolate (5-methyl- THF), which is used to synthesize methionine from homocysteine via the cobalamin-dependent enzyme methionine synthase (MTR).
    [Show full text]
  • The Vitamin B12 Coenzyme
    THE VITAMIN B12 COENZYME D. DoLPHIN, A. W. JoHNSON, R. RoDRIGO and N. SHAW Department of Chemistry, University of Nottingham, U.K. INTRODUCTION In 19•58 Barker and his associatesl-3 recognized a new coenzyme which controlled the conversion of glutamate into ß-methylaspartate by Clostridium tetanomorpkim. The coenzyme was shown4 to be related to !f;-vitamin B12, i.e. contair ing an adenine nucleotide grouping in place of the 5,6-dimethyl­ benziminawle nucleotide of vitamin B12, although similar coenzymes con­ taining btnziminazole or 5,6-dimethylbenziminazole were produced by growing C. tetanomorphum in the presence of the a ppropriate base5. Other variations of the nucleotide base have been achieved using Propionibacterium arabinosum in the presence of other purines and benziminazoles6• The pres­ ence of;:he coenzymes in a wide variety of micro-organisms such as several species of Actinomycetes including Streptomyces olivaceus and S. griseus has been dem( mstrated by the glutamate isomerase assay7 or by isolation. I t appears thü Vitamin B12 and its analogues are always biosynthesized in the form of their coenzymes. Preliminary physical and chemical studies sug­ gested that in the 5,6-dimethylbenzirninazolyl cobamide coenzyme the cyanide gr )up of vitamin B12, cyanocobalamin, was replaced by an adenine nucleoside':, 5, 8 and the determination9 of the complete structure (I; R = 5'-de·)xyadenosyl) of the coenzyme by X-ray analysis revealed the existence c f an essentially covalent bond between the cobalt atom and the S'.. carbon üom of the additional 5'-deoxyadenosine group. The molecule Me CH 2• CO· NH2 In the vitamin 8 12 coenzyme R =5' - deoxyadenosyl = Me Me 539 D.
    [Show full text]
  • The Potential Protective Role of Vitamin K in Diabetic Neuropathy
    VITAMINS The potential protective role of vitamin K in diabetic neuropathy DILIP MEHTA Viridis Biopharma 6/10 Jogani Industrial Complex ew cases of diabetes are symptomatic pain relief (3-5). V. N. Purav Marg, Chunabhatti increasing worldwide at a rapid Mumbai 400022, India The etiopathology of peripheral pace, with the total number of neuropathy is poorly understood and many [email protected] people with diabetes was projected factors, including dietary deficiencies, may www.viridisbiopharma.com Nto rise from 171 million in 2000 to 366 million contribute to the clinical manifestation of the in 2030 – an increase of nearly 200 million in condition. Deficiency of vitamin B12 (also only three decades. There are more cases of known as cobalamin), which results in a lack diabetes in women and urban populations, of a related compound, methylcobalamin, is with diabetes in developing countries projected manifested by megaloblastic anemia, and to double in the coming years (1). has been associated with significant Based on reports from the Centers for neurological pathology, especially peripheral Disease Control and Prevention, type 2 neuropathy (6-8). Vitamin B12 is also diabetes dult onset diabetes affects associated with the onset of diabetic approximately 9.3% of the general neuropathy. In patients with diabetic population in the United States in contrast to neuropathy, vitamin B12 deficiency may be 25.9% among those 65 years or older (2). aggravated by the use of antidiabetic agents Diabetes mellitus accounts for 90% of the such as metformin (9-11). Even short-term cases of diabetes patients (3,4). treatment with metformin causes a decrease The prevalence of type 2 diabetes in serum cobalamin, folic acid and an increases with age, higher then 25 body increase in homocysteine, which leads to mass index and the presence of the disease peripheral neuropathy in patients with in family history.
    [Show full text]
  • Potential Benefits of Methylcobalamin: a Review
    Open Access Austin Journal of Pharmacology and Therapeutics Review Article Potential Benefits of Methylcobalamin: A Review Gupta JK* and Qureshi Shaiba Sana Department of Pharmacology, GLA University Mathura, Abstract India Methylcobalamin is an active form of vitamin B12 that helps in synthesis *Corresponding author: Jeetendra Kumar Gupta, of methionine and S-adenosylmethionine. It is required for integrity of myelin, Department of Pharmacology, Institute of Pharmaceutical neuronal function, proper red blood cell formation and DNA synthesis. The largest Research, GLA University Mathura, India group of vitamin B12 deficiency is found in typical vegetarians all over the world, which can be alleviated with its analogue Methylcobalamin. It is a beneficial Received: August 17, 2015; Accepted: September 30, drug to most of the common disorders like cardiovascular disorders, diabetes, 2015; Published: October 08, 2015 anemia, hyperhomocysteinemia and degenerative disorders. Methylcobalamin helps in the synthesis of neuronal lipids, regeneration of axonal nerves and has neuroprotective activity, which promote neurons to function in proper way and thus improves Alzheimer disease, Parkinsonism, Dementia and neuropathic syndromes. It is an approved treatment for peripheral neuropathy. Keywords: Mecobalamin; Neuropathy; Anemia; Nootropic; Dietary supplement Abbreviations essential for cell growth and replication. Sometimes the liver cannot convert cyanocobalamin into adequate amount of methylcobalamin SAMe: S-Adenosyl Methionine; ERK: Extracellular Signal- needed for proper neuronal functioning. Through enhanced Regulated Kinases; PKB: Protein Kinase B; B-globulin: Beta Globulin; methylation, it exerts its nerve cell protective effect and accelerates ENFD: Epidermal Nerve Fiber Density; DPN: Diabetic Peripheral its growth. A lot of energy is required for cyanocobalamin to remove Neuropathy; NSAIDs: Non Steroidal Anti Inflammatory Drugs; THF: its cyanide and replaces it with methyl group [3].
    [Show full text]
  • Vitamin and Mineral Requirements in Human Nutrition
    P000i-00xx 3/12/05 8:54 PM Page i Vitamin and mineral requirements in human nutrition Second edition VITPR 3/12/05 16:50 Page ii WHO Library Cataloguing-in-Publication Data Joint FAO/WHO Expert Consultation on Human Vitamin and Mineral Requirements (1998 : Bangkok, Thailand). Vitamin and mineral requirements in human nutrition : report of a joint FAO/WHO expert consultation, Bangkok, Thailand, 21–30 September 1998. 1.Vitamins — standards 2.Micronutrients — standards 3.Trace elements — standards 4.Deficiency diseases — diet therapy 5.Nutritional requirements I.Title. ISBN 92 4 154612 3 (LC/NLM Classification: QU 145) © World Health Organization and Food and Agriculture Organization of the United Nations 2004 All rights reserved. Publications of the World Health Organization can be obtained from Market- ing and Dissemination, World Health Organization, 20 Avenue Appia, 1211 Geneva 27, Switzerland (tel: +41 22 791 2476; fax: +41 22 791 4857; e-mail: [email protected]). Requests for permis- sion to reproduce or translate WHO publications — whether for sale or for noncommercial distri- bution — should be addressed to Publications, at the above address (fax: +41 22 791 4806; e-mail: [email protected]), or to Chief, Publishing and Multimedia Service, Information Division, Food and Agriculture Organization of the United Nations, 00100 Rome, Italy. The designations employed and the presentation of the material in this publication do not imply the expression of any opinion whatsoever on the part of the World Health Organization and the Food and Agriculture Organization of the United Nations concerning the legal status of any country, territory, city or area or of its authorities, or concerning the delimitation of its frontiers or boundaries.
    [Show full text]
  • The Efficacy and Safety of Intramuscular Injections Of
    Original Article Singapore Med J 2011; 52(12) : 868 The efficacy and safety of intramuscular injections of methylcobalamin in patients with chronic nonspecific low back pain: a randomised controlled trial Chiu C K, Low T H, Tey Y S, Singh V A, Shong H K ABSTRACT both singly or in combination with other forms Introduction:Chronic, nonspecific low back of treatment. pain is a difficult ailment to treat and poses an economic burden in terms of medical Keywords: methylcobalamin, nonspecific low expenses and productivity loss. The aim of back pain, vitamin B12 this study was to determine the efficacy and Singapore Med J 2011; 52(12): 868-873 safety of intramuscular metylcobalamin in the treatment of chronic nonspecific low back INTRODUCTION pain. Low back pain (LBP) affects a substantial proportion of the population. Almost every person will encounter an Methods: This was a double-blinded, episode of back pain at some point in one’s life. Back randomised, controlled experimental study. pain does not discriminate based on gender, age, race or 60 patients were assigned to either the culture. It disables the working adult from performing his methylcobalamin group or the placebo group. duties and paralyses the society due to the cost incurred The former received intramuscular injections in terms of treatment and productivity loss. In 1988, a of 500 mcg parenteral methylcobalamin in 1 survey was conducted in a semirural area in Malaysia. Department of ml solution three times a week for two weeks, Orthopaedic A total of 2,594 individuals from a multi-racial (Malay, Surgery, and the placebo group received 1 ml normal Chinese, Indian) community were interviewed.
    [Show full text]
  • Cyanocobalamin-A Case for Withdrawal
    686 Journal of the Royal Society of Medicine Volume 85 November 1992 Cyanocobalamin- a case for withdrawal: discussion paper A G Freeman MD FRCP Meadow Rise, 3 Lakeside, Swindon SN3 IQE Keywords: anaemia, pernicious; optic neuropathies; chronic cyanide intoxication; hydroxocobalamin; cyanocobalamin It seems evident that controversy still surrounds the reduced ability to detoxify the cyanide in the tobacco- treatment of pernicious anaemia and other vitamin smoke to which they are exposed'0. B12 deficiency disorders. The long quest for the 'anti- Patients with tobacco amblyopia who have normal pernicious anaemia factor' in the liver seemed to serum vitamin B12 levels need not continue therapy have ended in 1948 when pure cyanocobalamin was with intramuscular hydroxocobalamin once their isolated. This was found to be very active thera- visual acuity and visual fields have returned to peutically when given by intramuscular injection and normal providing they abstain from further smoking. was non-toxic in extremely high doses'. However, those patients who have low serum vitamin Lederle, in a recent commentary2, advocates that B12 levels or evidence of -defective vitamin B12 patients with pernicious anaemia should now be absorption will need to continue-indefinitely with treated with oral cyanocobalamin. He is not without hydroxocobalamin irrespective of their smoking support in that 40% of patients with pernicious habits as will all patients with pernicious anaemia anaemia in Sweden are being similarly treated3. and other vitamin B12 deficiency disorders who are He further states that such!- treatment is cheap at risk of developing- optic neuropathy if they and effective, produces clinical and haematological are smokers.
    [Show full text]
  • Methylcobalamin/ B12 Liquid
    Product Information Sheet – January 2016 Methylcobalamin/ B12 liquid Introduced 2002 What Is It? Are There Any Potential Drug Interactions? Methylcobalamin is an activated, highly bioavailable form of vitamin At this time, there are no known adverse reactions when taken in B12, which acts as the principal circulating form of cobalamin in the conjunction with medications. body. It is available in liquid and capsule form.* Methylcobalamin Uses For Methylcobalamin Nervous System Health: In recent studies, methylcobalamin has each vegetarian capsule contains v 3 demonstrated an enhanced ability to support neurological function. vitamin B12 (as methylcobalamin) .................................................. 1,000 mcg other ingredients: hypoallergenic plant fiber (cellulose), vegetarian This form of vitamin B12 promotes protein synthesis for maintaining capsule (cellulose, water) healthy nerve cells and myelin. Methylcobalamin may also help to moderate levels of glutamate in the brain, encouraging healthy 1–3 capsules daily, in divided doses, with meals. brain cell activity, as well as memory, mood, and cognitive function. B liquid In general, vitamin B12 works with folate to promote DNA and red 12 blood cell health. Additionally, vitamin B12 is an important cofactor for energy metabolism and a vital component of the methionine one ml (0.03 fl oz) (one full dropper) contains v synthase pathway, which supports healthy homocysteine vitamin B12 ...................................................................................................1,000 mcg metabolism and S-adenosylmethionine (SAMe) production.* stevia .....................................................................................................................0.5 mg other ingredients: purified water, natural glycerin, citric acid, potassium What Is The Source? sorbate serving size: 1 ml (0.03 fl oz) (one full dropper) Pure Encapsulations methylcobalamin is produced from corn dextrose servings per container: 30 fermentation.
    [Show full text]
  • Route and Type of Formulation Administered Influences The
    Journal of Functional Biomaterials Article Route and Type of Formulation Administered Influences the Absorption and Disposition of Vitamin B12 Levels in Serum Luis Vitetta 1,2,* ID , Joyce Zhou 2, Rachel Manuel 2, Serena Dal Forno 2, Sean Hall 2 ID and David Rutolo 2 1 Sydney Medical School, The University of Sydney, Sydney 2006, Australia 2 Medlab Clinical, Sydney 2015, Australia; [email protected] (J.Z.); [email protected] (R.M.); [email protected] (S.D.F.); [email protected] (S.H.); [email protected] (D.R.) * Correspondence: [email protected] or [email protected] Received: 23 December 2017; Accepted: 18 January 2018; Published: 21 January 2018 Abstract: The administration of biological compounds that optimize health benefits is an ever-evolving therapeutic goal. Pharmaceutical and other adjunctive biological compounds have been administered via many different routes in order to produce a systemic pharmacological effect. The article summarizes the findings from an Australian comparative study in adults administered vitamin B12 through different oral delivery platforms. A total of 16 subjects (9 males, 7 females) voluntarily partook in a comparative clinical study of five different vitamin B12 formulations across a six-month period, completing 474 person-hours of cumulative contribution, that was equivalent to an n = 60 participation. A nanoparticle delivered vitamin B12 through a NanoCelle platform was observed to be significantly (p < 0.05) better absorbed than all other dose equivalent platforms (i.e., tablets, emulsions, or liposomes) from baseline to 1, 3, and 6 h of the study period. The nanoparticle platform delivered vitamin B12 demonstrated an enhanced and significant absorption profile as exemplified by rapid systemic detection (i.e., 1 h from baseline) when administered to the oro-buccal mucosa with no reports of any adverse events of toxicity.
    [Show full text]
  • Summary Report
    Pyridoxal 5-Phosphate: Summary Report Item Type Report Authors Gianturco, Stephanie L.; Pavlech, Laura L.; Storm, Kathena D.; Yoon, SeJeong; Yuen, Melissa V.; Mattingly, Ashlee N. Publication Date 2019-12 Keywords Pyridoxal; Compounding; Food, Drug, and Cosmetic Act, Section 503B; Food and Drug Administration; Outsourcing facility; Drug compounding; Legislation, Drug; United States Food and Drug Administration; Pyridoxal Phosphate Rights Attribution-NoDerivatives 4.0 International Download date 02/10/2021 21:53:32 Item License http://creativecommons.org/licenses/by-nd/4.0/ Link to Item http://hdl.handle.net/10713/12348 Summary Report Pyridoxal 5-Phosphate Prepared for: Food and Drug Administration Clinical use of bulk drug substances nominated for inclusion on the 503B Bulks List Grant number: 2U01FD005946 Prepared by: University of Maryland Center of Excellence in Regulatory Science and Innovation (M-CERSI) University of Maryland School of Pharmacy December 2019 This report was supported by the Food and Drug Administration (FDA) of the U.S. Department of Health and Human Services (HHS) as part of a financial assistance award (U01FD005946) totaling $2,342,364, with 100 percent funded by the FDA/HHS. The contents are those of the authors and do not necessarily represent the official views of, nor an endorsement by, the FDA/HHS or the U.S. Government. 1 Table of Contents REVIEW OF NOMINATION ..................................................................................................... 4 METHODOLOGY ...................................................................................................................
    [Show full text]
  • Nutrition Journal of Parenteral and Enteral
    Journal of Parenteral and Enteral Nutrition http://pen.sagepub.com/ Micronutrient Supplementation in Adult Nutrition Therapy: Practical Considerations Krishnan Sriram and Vassyl A. Lonchyna JPEN J Parenter Enteral Nutr 2009 33: 548 originally published online 19 May 2009 DOI: 10.1177/0148607108328470 The online version of this article can be found at: http://pen.sagepub.com/content/33/5/548 Published by: http://www.sagepublications.com On behalf of: The American Society for Parenteral & Enteral Nutrition Additional services and information for Journal of Parenteral and Enteral Nutrition can be found at: Email Alerts: http://pen.sagepub.com/cgi/alerts Subscriptions: http://pen.sagepub.com/subscriptions Reprints: http://www.sagepub.com/journalsReprints.nav Permissions: http://www.sagepub.com/journalsPermissions.nav >> Version of Record - Aug 27, 2009 OnlineFirst Version of Record - May 19, 2009 What is This? Downloaded from pen.sagepub.com by Karrie Derenski on April 1, 2013 Review Journal of Parenteral and Enteral Nutrition Volume 33 Number 5 September/October 2009 548-562 Micronutrient Supplementation in © 2009 American Society for Parenteral and Enteral Nutrition 10.1177/0148607108328470 Adult Nutrition Therapy: http://jpen.sagepub.com hosted at Practical Considerations http://online.sagepub.com Krishnan Sriram, MD, FRCS(C) FACS1; and Vassyl A. Lonchyna, MD, FACS2 Financial disclosure: none declared. Preexisting micronutrient (vitamins and trace elements) defi- for selenium (Se) and zinc (Zn). In practice, a multivitamin ciencies are often present in hospitalized patients. Deficiencies preparation and a multiple trace element admixture (containing occur due to inadequate or inappropriate administration, Zn, Se, copper, chromium, and manganese) are added to par- increased or altered requirements, and increased losses, affect- enteral nutrition formulations.
    [Show full text]
  • Vitamin C, Vitamin B12, Vitamin K Mk7, Folate Capsule Vivera Pharmaceuticals, Inc
    FOLINEX- vitamin c, vitamin b12, vitamin k mk7, folate capsule Vivera Pharmaceuticals, Inc. Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here. ---------- FOLINEXTM FACTS Folinex™ is an orally administered prescription folate product for the dietary management of patients with unique nutritional needs requiring increased folate levels and other nutritional supplementation. Folinex™ should be administered under the supervision of a licensed medical practitioner. Folinex™ is used for dietary management of patients with unique nutritional needs requiring increased folate levels, or are in need of other nutritional supplementation. Folinex™ can be taken by women of childbearing age, pregnant women, and lactating and nonlactating mothers under the supervision of a licensed medical practitioner. PRECAUTIONS Tell your doctor if you have: kidney problems or thyroid disease. This medication should be used as directed during pregnancy or while breast-feeding. Consult your doctor about the risks and benefits. Folic acid alone is improper therapy in the treatment of pernicious anemia and other megaloblastic anemias where vitamin B12 is deficient. Folic acid in doses above 0.1 mg daily may obscure pernicious anemia in that hematologic remission can occur while neurological manifestations progress. WARNINGS Allergic sensitization has been reported following both oral and parenteral administration of folic acid. You should call your doctor for medical advice about serious adverse events. DOSAGE AND ADMINISTRATION Usual adult dose is one (1) tablet once or twice daily or as prescribed by a licensed medical practitioner.* If you are pregnant or nursing, ask a healthcare professional.
    [Show full text]