Scientific Documentation B1196, Butylated Hydroxytoluene, Granular, NF 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 25.August.2021 B1196, Butylated Hydroxytoluene, Granular, NF Table of Contents Product Specification Certificate of Analysis Sample(s) Safety Data Sheet (SDS) Certification of Current Good Manufacturing Practices (cGMP) Source Statement BSE/TSE Statement Allergen Statement EU Fragrance 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 Butylated Hydroxytoluene, Granular, NF (B1196) Item Number B1196 Item Butylated Hydroxytoluene, Granular, NF CAS Number 128-37-0 Molecular Formula C15H24O Molecular Weight 220.36 MDL Number Synonyms BHT ; Butylated Hydroxytoluene ; 2,6-Di-tert-butyl-p-cresol Test Specification Min Max APPEARANCE SPECTRUM MATCHES IDENTIFICATION A) FTIR REFERENCE RETENTION TIME IDENTIFICATION B (HPLC) MATCHES STANDARD ASSAY 99.0 101.5 % RESIDUE ON IGNITION 0.002 % ELEMENTAL IMPURITIES: LEAD (Pb) AS REPORTED ARSENIC (As) AS REPORTED ORGANIC IMPURITIES: p-Cresol or m-cresol 0.1 % 3-tert-Butyl-4-hydroxyanisole (BHA) 0.1 % 3,5-Di-tert-butyl-4-hydroxybenzoic acid 0.1 % 2-tert-butyl-4-methylphenol or 2-tert-butyl-5-methylphenol 0.1 % 3,5-Di-tert-butyl-4-hydroxy benzaldehyde 0.1 % 4,6-Di-tert-butyl-m-cresol 0.1 % 2,6-Di-tert-butyl-phenol 0.1 % INDIVIDUAL IMPURITY 0.1 % TOTAL IMPURITIES 0.7 % CERTIFIED KOSHER CERTIFIED HALAL RETEST DATE MANUFACTURE DATE RESIDUAL SOLVENTS AS REPORTED MONOGRAPH EDITION Certificate Of Analysis Item Number B1196 Lot Number 1KG0917 Item Butylated Hydroxytoluene, Granular, NF CAS Number 128-37-0 Molecular Formula C15H24O Molecular Weight 220.36 Test Specification Result min max APPEARANCE WHITE GRANULES SPECTRUM SPECTRUM IDENTIFICATION A) FTIR MATCHES MATCHES REFERENCE REFERENCE RETENTION RETENTION IDENTIFICATION B (HPLC) TIME MATCHES TIME MATCHES STANDARD STANDARD ASSAY 99.0 101.5 % 99.9 % RESIDUE ON IGNITION 0.002 % 0.0004 % ELEMENTAL IMPURITIES: . LEAD (Pb) AS REPORTED <0.5 µg/g ARSENIC (As) AS REPORTED <1.5 µg/g ORGANIC IMPURITIES: . p-Cresol or m-cresol 0.1 % <0.1 % 3-tert-Butyl-4-hydroxyanisole (BHA) 0.1 % <0.1 % 3,5-Di-tert-butyl-4-hydroxybenzoic acid 0.1 % <0.1 % 2-tert-butyl-4-methylphenol or 2-tert-butyl-5- methylphenol 0.1 % <0.1 % 3,5-Di-tert-butyl-4-hydroxy benzaldehyde 0.1 % <0.1 % 4,6-Di-tert-butyl-m-cresol 0.1 % <0.1 % 2,6-Di-tert-butyl-phenol 0.1 % <0.1 % INDIVIDUAL IMPURITY 0.1 % <0.1 % TOTAL IMPURITIES 0.7 % <0.7 % CERTIFIED KOSHER CERTIFIED KOSHER CERTIFIED HALAL CERTIFIED HALAL RETEST DATE 15-JUL-2024 MANUFACTURE DATE 15-JUL-2021 NO RESIDUAL RESIDUAL SOLVENTS AS REPORTED SOLVENTS USED MONOGRAPH EDITION (NF) 38 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. SAFETY DATA SHEET Preparation Date: 4/24/2014 Revision date 7/31/2019 Revision Number: G6 1. IDENTIFICATION Product identifier Product code: B1196 Product Name: BUTYLATED HYDROXYTOLUENE, GRANULAR, NF Other means of identification Synonyms: BHT Butylhydroxytoluene p-Cresol, 2,6-di-tert-butyl- Butylated Hydroxytoluene Ionol 2,6-Di-tert-butyl-p-cresol 2,6-Bis(1,1-dimethylethyl)-4-methylphenol 2,6-Di-tert-butyl-1-hydroxy-4-methylbenzene 2,6-Di-tert-butyl-p-methylphenol 3,5-Di-tert-butyl-4-hydroxytoluene 4-Methyl-2,6-di-tert-butylphenol CAS #: 128-37-0 RTECS # GO7875000 CI#: Not available Recommended use of the chemical and restrictions on use Recommended use: FOOD ADDITIVE; ANTIOXIDANT FOR SYNTHETIC RUBBERS, PLASTICS, SOAPS, ANIMAL & VEGETABLE OILS; ANTISKINNING AGENT IN PAINTS & INKS; IN CHEWING GUM BASE, PACKAGING MATERIALS, BUTTER, CANDY, PARAFFIN & MINERAL OILS; EMPLOYED TO RETARD OXIDATIVE DEGRADATION OF OILS & FATS IN VARIOUS COSMETICS & PHARMACEUTICALS. 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 considered hazardous by the 2012 OSHA Hazard Communication Standard (29 CFR 1910.1200) Considered a dangerous substance or mixture according to the Globally Harmonized System (GHS) Product code: B1196 Product name: BUTYLATED Page 1 / 13 HYDROXYTOLUENE, GRANULAR, NF Acute toxicity - Oral Category 4 Skin corrosion/irritation Category 2 Serious eye damage/eye irritation Category 2A Label elements Warning Hazard statements Harmful if swallowed Causes skin irritation Causes serious eye irritation Hazards not otherwise classified (HNOC) Not Applicable Other hazards Toxic to aquatic life with long lasting effects Toxic to aquatic life Precautionary Statements - Prevention Wash face, hands and any exposed skin thoroughly after handling Do not eat, drink or smoke when using this product Wear protective gloves/protective clothing/eye protection/face protection Precautionary Statements - Response IF IN EYES: Rinse cautiously with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing. If eye irritation persists: Get medical attention. IF ON SKIN: Wash with plenty of water If skin irritation occurs: Get medical attention Take off contaminated clothing and wash it before reuse IF SWALLOWED: Call a POISON CENTER or physician if you feel unwell Rinse mouth Precautionary Statements - Disposal Dispose of contents and container to an approved waste disposal plant in accordance with local, regional, national and international regulations as applicable 3. COMPOSITION/INFORMATION ON INGREDIENTS Component CAS No Weight-% Butylated Hydroxytoluene 128-37-0 100 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 Product code: B1196 Product name: BUTYLATED Page 2 / 13 HYDROXYTOLUENE, GRANULAR, NF 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 skin irritation persists, call a physician. Eye Contact: Flush eyes with water for 15 minutes. Get medical attention. 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. Obtain medical attention. Most important symptoms and effects, both acute and delayed Symptoms Irritating to eyes and skin Vomiting Nausea May cause diarrhea Respiratory depression Central nervous system effects Tremors 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: Dry chemical. Carbon dioxide (CO2). Water spray mist or foam. Unsuitable Extinguishing Media: No information available. Specific hazards arising from the chemical Hazardous combustion products Carbon Monoxide, Carbon Dioxide. Specific hazards May be combustible at high temperatures. 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 Product code: B1196 Product name: BUTYLATED