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Manufacturing Process Flowchart Dibasic Potassium Phosphate, Anhydrous, USP, EP, BP - PO204

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Manufacturing Process Flowchart Dibasic Potassium Phosphate, Anhydrous, USP, EP, BP - PO204 Scientific Documentation PO204, Dibasic Potassium Phosphate, Anhydrous, USP, EP, BP Not appropriate for regulatory submission. Please visit www.spectrumchemical.com or contact Tech Services for the most up‐to‐date information contained in this information package. Spectrum Chemical Mfg Corp 769 Jersey Avenue New Brunswick, NJ 08901 Phone 732.214.1300 Ver4.06 28.January.2021 PO204, Dibasic Potassium Phosphate, Anhydrous, USP, EP, BP Table of Contents Product Specification Certificate of Analysis Sample(s) Safety Data Sheet (SDS) Certification of Current Good Manufacturing Practices (cGMP) Manufacturing Process Flowchart Source Statement BSE/TSE Statement Allergen Statement GMO Statement Melamine Statement Nitrosamine Statement Animal Testing Statement Organic Compliance Statement Shelf Life Statement Other Chemicals Statement Elemental Impurities Statement Residual Solvents Statement General Label Information – Sample Label General Lot Numbering System Guidance Kosher Certificate Halal Certificate Specification for Dibasic Potassium Phosphate, Anhydrous, USP, EP, BP (PO204) Item Number PO204 Item Dibasic Potassium Phosphate, Anhydrous, USP, EP, BP CAS Number 7758-11-4 Molecular Formula K2HPO4 Molecular Weight 174.18 MDL Number Synonyms Dipotassium Hydrogen Phosphate ; Dipotassium Phosphate Test Specification Min Max ASSAY (K2HPO4; DRIED BASIS) 98.0 100.5 % pH OF A 1 IN 20 SOLUTION 8.5 9.6 LOSS ON DRYING 1.0 % INSOLUBLE SUBSTANCES 0.2 % NOT MORE THAN A FEW CARBONATE BUBBLES ARE EVOLVED CHLORIDE (Cl) 0.02 % SULFATE 0.1 % ARSENIC (As) 2 ppm IRON (Fe) 0.001 % SODIUM (Na) NO YELLOW COLOR SODIUM (EP) 0.1 % ELEMENTAL IMPURITIES AS REPORTED FLUORIDE 0.001 % MONOBASIC OR TRIBASIC SALT 0.4 ml MONOPOTASSIUM PHOSPHATE 2.5 % APPEARANCE OF SOLUTION CLEAR AND COLORLESS REDUCING SUBSTANCES SOLUTION REMAINS PINK IDENTIFICATION (A) POSITIVE FOR POTASSIUM IDENTIFICATION (B) POSITIVE FOR PHOSPHATE IDENTIFICATION (C) SLIIGTHLY ALKALINE CERTIFIED KOSHER CERTIFIED HALAL APPEARANCE EXPIRATION DATE DATE OF MANUFACTURE RESIDUAL SOLVENTS AS REPORTED MONOGRAPH EDITION (USP) MONOGRAPH EDITION (EP) MONOGRAPH EDITION (BP) Certificate Of Analysis Item Number PO204 Lot Number 1JL0451 Item Dibasic Potassium Phosphate, Anhydrous, USP, EP, BP Manufacturer Lot 26660022 CAS Number 7758-11-4 Manufacturer Code 283 Molecular Formula K2HPO4 Molecular Weight 174.18 Test Specification Result min max ASSAY (K2HPO4; DRIED BASIS) 98.0 100.5 % 98.6 % pH OF A 1 IN 20 SOLUTION 8.5 9.6 9.3 LOSS ON DRYING 1.0 % 0.22 % INSOLUBLE SUBSTANCES 0.2 % 0.00 % NOT MORE THAN NOT MORE THAN CARBONATE A FEW BUBBLES A FEW BUBBLES ARE EVOLVED ARE EVOLVED CHLORIDE (Cl) 0.02 % <0.02 % SULFATE 0.1 % <0.1 % ARSENIC (As) 2 ppm 0.14 ppm IRON (Fe) 0.001 % <0.001 % SODIUM (Na) NO YELLOW NO YELLOW COLOR COLOR SODIUM (EP) 0.1 % <0.04 % ELEMENTAL IMPURITIES COMPLIES WITH AS REPORTED STANDARD FLUORIDE 0.001 % 0.0001 % MONOBASIC OR TRIBASIC SALT 0.4 ml <0.4 ml MONOPOTASSIUM PHOSPHATE 2.5 % <2.5 % APPEARANCE OF SOLUTION CLEAR AND CLEAR AND COLORLESS COLORLESS REDUCING SUBSTANCES SOLUTION SOLUTION REMAINS PINK REMAINS PINK IDENTIFICATION (A) POSITIVE FOR POSITIVE FOR POTASSIUM POTASSIUM IDENTIFICATION (B) POSITIVE FOR POSITIVE FOR PHOSPHATE PHOSPHATE IDENTIFICATION (C) SLIIGTHLY SLIIGTHLY ALKALINE ALKALINE CERTIFIED KOSHER CERTIFIED KOSHER CERTIFIED HALAL CERTIFIED HALAL APPEARANCE WHITE GRANULAR POWDER EXPIRATION DATE 21-SEP-2023 DATE OF MANUFACTURE 21-SEP-2020 RESIDUAL SOLVENTS NO RESIDUAL AS REPORTED SOLVENTS USED MONOGRAPH EDITION (USP) (USP) 43 MONOGRAPH EDITION (EP) (EP) 10 MONOGRAPH EDITION (BP) (BP) 2020 Spectrum Chemical Mfg Corp 14422 South San Pedro Street Gardena 90248 CA All pharmaceutical ingredients are tested using current edition of applicable pharmacopeia. Read and understand label and SDS before handling any chemicals. All Spectrum's chemicals are for manufacturing, processing, repacking or research purposes by experienced personnel only. It is the customer's responsibility to provide adequate hazardous material training and ensure that appropriate Personal Protective Equipment (PPE) is used before handling any chemical. The Elemental Impurities standards implemented by USP and other Pharmaceutical Compendia reflect a growing understanding of the toxicology of trace levels of elemental impurities that can remain in drug substances originating from either raw materials or manufacturing processes. Identifying and quantifying impurities can be critical to predicting the best possible patient outcomes. Elemental Impurities has been a requirement of all products meeting USP/NF, EP and BP monographs since January 1, 2018. More information can be found in USP sections <232> Elemental Impurities – Limits and <233> Elemental Impurities – Procedures. Data for drug substances furnished by Spectrum Chemical Mfg. Corp can be used to ensure that patient daily exposures by oral administration to the selected elements are not exceeded in the formulation of pharmaceutical products. Spectrum Chemical Mfg. Corp. repackages Active Pharmaceutical Ingredient chemicals provided by other manufacturers and suppliers. For traceability purposes, Spectrum's Certificate of Analysis contains an identifier code unique to each manufacturer or supplier, as well as the chemical's lot number provided on the original manufacturer Certificate of Analysis. This material is manufactured by Jost Chemical Co. at 8150 Lackland, St. Louis, MO 63114. Copies of the original Certificate of Analysis are available upon request from your Spectrum Sales Representative or by calling Spectrum's Quality Department at 1-800-772-8786. SAFETY DATA SHEET Preparation Date: 7/27/2014 Revision date 2/2/2018 Revision Number: G2 1. IDENTIFICATION Product identifier Product code: PO204 Product Name: DIBASIC POTASSIUM PHOSPHATE, ANHYDROUS, USP, EP, BP Other means of identification Synonyms: Dipotassium Phosphate; Dipotassium hydrogen phosphate; Dipotassium monohydrogen phosphate; Phosphoric acid, dipotassium salt CAS #: 7758-11-4 RTECS # TC5580000 CI#: Not available Recommended use of the chemical and restrictions on use Recommended use: Buffer. Uses advised against No information available Supplier: Spectrum Chemical Mfg. Corp 14422 South San Pedro St. Gardena, CA 90248 (310) 516-8000 Order Online At: https://www.spectrumchemical.com Emergency telephone number Chemtrec 1-800-424-9300 Contact Person: Tom Tyner (USA - West Coast) Contact Person: Ibad Tirmiz (USA - East Coast) 2. HAZARDS IDENTIFICATION Classification This chemical is not considered hazardous by the 2012 OSHA Hazard Communication Standard (29 CFR 1910.1200) Not a dangerous substance or mixture according to the Globally Harmonized System (GHS) Label elements Not classified Hazards not otherwise classified (HNOC) Not Applicable Product code: PO204 Product name: DIBASIC POTASSIUM Page 1 / 11 PHOSPHATE, ANHYDROUS, USP, EP, BP Other hazards Not available 3. COMPOSITION/INFORMATION ON INGREDIENTS Component CAS No Weight-% Potassium Phosphate Dibasic, Anhydrous 7758-11-4 100 4. FIRST AID MEASURES First aid measures General Advice: National Capital Poison Center in the United States can provide assistance if you have a poison emergency and need to talk to a poison specialist. Call 1-800-222-1222. Skin Contact: Wash off immediately with soap and plenty of water removing all contaminated clothing and shoes. Get medical attention if irritation develops. Consult a physician if necessary. Eye Contact: Flush eyes with water for 15 minutes. Get medical attention if irritation occurs. If symptoms persist, call a physician. Inhalation: Move to fresh air. If not breathing, give artificial respiration. If breathing is difficult, give oxygen. Get medical attention. Ingestion: Do not induce vomiting without medical advice. Never give anything by mouth to an unconscious person. Consult a physician if necessary. Most important symptoms and effects, both acute and delayed Symptoms May cause eye/skin irritation May cause digestive (gastrointestinal) tract irritation May cause abdominal discomfort May cause nausea and vomiting May cause diarrhea Indication of any immediate medical attention and special treatment needed Notes to Physician: Treat symptomatically. Protection of first-aiders First-Aid Providers: Avoid exposure to blood or body fluids. Wear gloves and other necessary protective clothing. Dispose of contaminated clothing and equipment as bio-hazardous waste. 5. FIRE-FIGHTING MEASURES Extinguishing Media Suitable Extinguishing Media: The product is not flammable. If it is involved in a fire, extinguish the fire using an agent suitable for the type of surrounding fire. Unsuitable Extinguishing Media: No information available. Specific hazards arising from the chemical Product code: PO204 Product name: DIBASIC POTASSIUM Page 2 / 11 PHOSPHATE, ANHYDROUS, USP, EP, BP Hazardous combustion products If it is involved in a fire the following can be released:. Oxides of phosphorus. Potassium oxides. Specific hazards No information available. Special Protective Actions for Firefighters Specific Methods: No information available Special Protective Equipment for Firefighters: As in any fire, wear self-contained breathing apparatus pressure-demand, MSHA/NIOSH (approved or equivalent) and full protective gear 6. ACCIDENTAL RELEASE MEASURES Personal precautions, protective equipment and emergency procedures Personal Precautions: Ensure adequate ventilation. Use personal protective equipment. Avoid contact with skin, eyes and clothing. Avoid dust formation. Environmental precautions Prevent
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