bioCERTIFIED Products for Compounding Pharmacies
Meet increasing quality, safety and regulatory requirements with confidence with Spectrum Pharmacy's bioCERTIFIED™ Quality Management System and products.
Featuring expanded laboratory testing, certifications and documentation, our bioCERTIFIED portfolio is tailored to meet compliance requirements for compounding pharmacies.
bioCERTIFIED products help you simplify and standardize to ensure success. And they are backed by Spectrum Pharmacy's "100% Tested and 100% Transparent" guarantee. All raw materials and finished goods are subject to in-house testing in our cGMP-compliant facilities to ensure that all chemicals and ingredients meet stringent quality standards.
bioCERTIFIED products have undergone additional testing for bioburden, endotoxin and elemental impurities.
Spectrum Pharmacy's extensive knowledge and experience in the changing compounding pharmacy landscape also ensure that our products — and YOURS — are compliant with regulatory standards. Additionally, documented change controls and sourcing ensure full supply chain transparency.
With Spectrum Pharmacy bioCERTIFIED materials, you gain an industry-leading support team and strict quality and certification processes to ensure product consistency, predictability and performance. Think of us as an extension of your quality control system. We provide comprehensive testing, scientific documentation and customization to meet your requirements, reduce your workload.
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Full testing for every lot — Standard tests by lot include bioburden, endotoxin and elemental impurities. Additional tests available.
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Comprehensive regulatory and scientific documentation — Professionally prepared dossiers succinctly provide all required documentation on pilot, scale-up and production chemicals.
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Change control and batch traceability — Complete supply chain transparency and traceability.
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Three in-house analytical testing labs — U.S. locations are ISO 9001:2015.
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Extensive product breadth and availability — Globally sourced products include amino acids, biological buffers, inorganic salts, sugars, carbohydrates, cleaning-in-place solutions and more.
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Biopharm industry standard CFR 210/211 cGMP packaging facilities — Custom and batch-specific packaging, labeling, production sizes, and documentation to meet specific customer requirements.
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Scale-up and streamlined speed to market support — Flexibility to accommodate different requirements from pilot to small-medium pre-packaged and bulk sizes.
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Industry-leading support — Expert technical service and consultative support for sales, regulatory, quality management, purchasing and manufacturing teams.
Cat. No. | Product Description | Size Range | Grade |
B8200 |
Benzyl Alcohol, NF, EP, BP, JP, bioCERTIFIED™ |
500 ML, 1, 4, 25 (LT) |
NF, EP, BP, JP, bioCERTIFIED™ |
Glycerin (Glycerol) Natural, USP, EP, BP, JP, FCC, bioCERTIFIED™ |
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H9400 |
L-Histidine, USP, JP, bioCERTIFIED™ |
1, 2.5, 12 (KG) |
USP, JP, bioCERTIFIED™ |