inorganic inorganic salts forsalts forbiopharmaceuticalbiopharmaceuticalmanufacturingmanufacturing

Macco OrganiquesBringing Minerals to Life

Macco offers physically modified mineral salts & customized packaging, including blending, grinding/crushing, milling and repackaging (upon request). All products are packed in a GMP Q7 certified facility equipped with clean rooms conforming to ISO 8 standards. Macco has a passion for quality and for prevention of contamination throughout all production stages, which is why they were hand-selected by Spectrum to be our manufacturing partner for biopharma and parenteral drug products.

Certifications and Registrations• GMP ICH Q7• FSSC 22000• ISO 9001• FDA inspected• CoS/CEP• US Drug Master File• Japanese Drug Master File• ASMF

Quality Standards• EP (European Pharmacopeia)• BP (British Pharmacopeia)• USP (U.S. Pharmacopeia) • JP (Japanese Pharmacopeia)• FCC (Food Chemical Codex)• ACS (American Chemical Society)• ChP (Chinese Pharmacopeia)

Spectrum Chemical Mfg. Corp.Trusted Since 1971

Spectrum has been serving quality-driven industries for nearly five decades, and we’ve earned the trust of our customers by consistently offering the highest quality chemicals and raw materials. We are proud to offer the Macco brand to our customers, as we continue to grow our high-quality product offering for biopharma and parenteral drug manufacturers.

Spectrum Chemical Mfg. Corp. has invested in facilities, personnel and regulatory certifications so that our quality driven customers get the right materials from the start, minimizing downstream production risks.

Spectrum No. Product Description Size Grade

5070400 Ammonium Sulfate 200 g, 12 Kg, 50 Kg USP, ACS, pyrogen free

5200302 Calcium Chloride Dihydrate 200 g, 12 Kg USP, EP, BP, JP, FCC, ACS, pyrogen free

5120306 Magnesium Chloride Hexahydrate 200 g, 12 Kg, 50 Kg USP, EP, BP, JP, FCC, ACS, pyrogen free

5120407 Magnesium Sulfate Heptahydrate 200 g, 12 Kg USP, EP, BP, FCC, pyrogen free

5190300 Potassium Chloride 200 g, 12 Kg USP, EP, BP, FCC

5111431 Potassium Hydrogen Carbonate 200 g, 12 Kg EP, FCC

5110103 Sodium Acetate Trihydrate 200 g, 12 Kg USP, EP, BP, FCC, pyrogen free

5110600 Sodium Bicarbonate 200 g, 12 Kg USP, EP, BP, FCC, pyrogen free

5110200 Sodium Carbonate Anhydrous 200 g, 12 Kg USP, FCC

5110300 Sodium Chloride 200 g, 12 Kg, 50 Kg USP, EP, BP, JP, FCC, pyrogen free

5111507 Sodium Phosphate Dibasic Heptahydrate 200 g, 12 Kg USP, EP

5111501 Sodium Phosphate Monobasic Monohydrate 200 g, 12 Kg USP, EP, BP, FCC, pyrogen free

5110400 Sodium Sulfate Anhydrous 200 g, 12 Kg USP, EP

5300401 Zinc Sulfate Monohydrate 200 g, 12 Kg USP, EP, FCC

The Right Materials From The Start• Biopharm industry standard CFR 210/211 cGMP packaging facilities• Full testing for every lot: bioburden, endotoxin and elemental impurities• Supply chain verification• Temperature controlled warehouse• Technical Service• CAPA Programs• Comprehensive regulatory & scientific documentation• Change control & batch traceability• 4 Analytical Testing Labs• US Locations ISO 9001:2015 • China Laboratory ISO 17025

™

Macco products are offered as part of Spectrum’s bioCERTIFIED™ program for biopharmaceutical ingredients.

800.772.8786 · SpectrumChemical.com

LB1105_2019_D

Spectrum Chemical Mfg. Corp.

USA / Canada: 1.800.772.8786Latin America / Europe: 1.310.516.8000Asia Pacific: +86-21-67601398

SpectrumChemical.comsales@spectrumchemical.com

New JerseyCorporate HeadquartersISO 9001:2015 • cGMP • FDA RegisteredManufacturing, Distribution & QC Labs769 Jersey Avenue New Brunswick, NJ 08901-3605

CaliforniaISO 9001:2015 • cGMP • FDA RegisteredManufacturing, Distribution & QC Labs14422 S. San Pedro StreetGardena, CA 90248-2027

ChinaISO 17025 • FDA RegisteredManufacturing, Distribution & QC Labs3802 Shen Gang Road, Bldg A20,Song Jiang District, Shanghai, China 201611