Chondroitin Sulfate Sodium Salt, USP Dietary Supplement

Pharmaceutical Chemical Ingredients

USP NF FCC BP EP JP Grade Products

Tariff No. 2932999090

For laboratory research and development purposes only. Unless otherwise expressly noted by the manufacturer of the product on the product labeling and documentation.

WARNING: Cancer and Reproductive Harm - www.P65Warnings.ca.gov

The California and New Jersey plants are also FDA registered drug establishments and operate under current Good Manufacturing Practices (cGMP). The manufacturer has in place all the documentation, validation, and qualification systems expected by all quality-driven organizations to meet your regulatory requirements. Manufacturer facilities headquartered on 17 acres in New Brunswick, NJ and has production, quality control laboratories, warehousing and distribution facilities in New Brunswick, NJ and Gardena, CA. All manufacturer's US production facilities are ISO 9001:2015 certified, FDA registered and operate under current Good Manufacturing Practices (cGMP). The manufacturer conducts in-house QC testing by lot to safeguard quality at each facility and provide extensive regulatory and scientific documentation to ensure compliance. The manufacturer also offers change control, lot traceability and supply chain transparency to eliminate unpredictability. Meanwhile, products are manufactured, packaged and stored under cGMP in FDA-registered and inspected facilities. The manufacturer has a quality control team of more than 30 chemists and technicians perform over 20,000 tests each year in our ISO 9001-2015 in-house, certified testing facilities in California, New Jersey and Shanghai. This ensures safe ingredients for pharmaceutical and biopharmaceutical products.The New Brunswick, NJ Corporate headquarters contains 200,000 sq ft of manufacturing, laboratory and warehousing space. This facility features CFR 210/211 cGMP biopharma standard packaging capabilities and is FDA registered. This facility is also the site of our Pharmacy Division, Spectrum Pharmacy Products. With over 125,000 sq ft of manufacturing, laboratory and warehousing space, their ISO 9001-2015-certified Gardena, CA facility is also FDA and DEA registered.

TO PASS TEST

CHONDROITIN SULFATE SODIUM (DRIED BASIS): 90.0 % (MIN); 105.0 % (MAX) SPECIFIC ROTATION, [a]D25: -20.0° to -30.0° (MIN) RESIDUE ON IGNITION: 20.0 % (MIN); 30.0 % (MAX) pH (1 IN 100): 5.5 (MIN); 7.5 (MAX) CLARITY AND COLOR OF SOLUTION: TO PASS TEST (MIN) LOSS ON DRYING: 12.0 % (MAX) NONSPECIFIC DISSACCHARIDES: 10 % (MAX) PROTEIN: 6.0 % (MAX) CHLORIDE: 0.50 % (MAX) SULFATE: 0.24 % (MAX) ELEMENTAL IMPURITIES: CADMIUM (Cd): AS REPORTED (MIN) LEAD (Pb): AS REPORTED (MIN) ARSENIC (As): AS REPORTED (MIN) MERCURY (Hg): AS REPORTED (MIN) CHROMIUM (Cr): AS REPORTED (MIN) ELECTROPHORETIC PURITY: TO PASS TEST (MIN) MICROBIAL LIMITS: TOTAL BACTERIAL COUNT: 10³ cfu/g (MAX) TOTAL YEASTS AND MOLDS COUNT: 10² cfu/g (MAX) SALMONELLA: NEGATIVE (MIN) ESCHERICHIA COLI: NEGATIVE (MIN) RESIDUAL SOLVENTS: TO PASS TEST (MIN)

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