bioCERTIFIED Products for Compounding Pharmacies

100% Tested. 100% Transparent.  100% Trusted.
Meet compliance requirements with bioCERTIFIED™ chemicals.

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 SpectrumPharmacy 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.

 

  • Full testing for every lot — Standard tests by lot include bioburden, endotoxin and elemental impurities. Additional tests available.

  • Comprehensive regulatory and scientific documentation — Professionally prepared dossiers succinctly provide all required documentation on pilot, scale-up and production chemicals.

  • Change control and batch traceability — Complete supply chain transparency and traceability.

  • Three in-house analytical testing labs — U.S. locations are ISO 9001:2015 while Shanghai, China, facility is ISO 17025.

  • Extensive product breadth and availability — Globally sourced products include amino acids, biological buffers, inorganic salts, sugars, carbohydrates, cleaning-in-place solutions and more.

  • Biopharm industry standard CFR 210/211 cGMP packaging facilities — Custom and batch-specific packaging, labeling, production sizes, manufacturing solutions and documentation to meet specific customer requirements.

  • Scale-up and streamlined speed to market support — Flexibility to accommodate different requirements from pilot to small-medium pre-packaged and bulk sizes.

  • 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

AS922

Ascorbic Acid, USP, bioCERTIFIED™

1, 2.5, 12, 50 (KG)

USP, bioCERTIFIED™

B8200

Benzyl Alcohol, NF, EP, BP, JP, bioCERTIFIED™

500 ML, 1, 4, 25 (LT)

NF, EP, BP, JP, bioCERTIFIED™

B8210

Benzyl Alcohol, Parenteral Grade, NF, bioCERTIFIED™

500 ML, 4 LT

NF, bioCERTIFIED™

CH924

Chlorobutanol, Anhydrous, NF, bioCERTIFIED™

500 GM

NF, bioCERTIFIED™

CY900

Cyclopentolate Hydrochloride, USP, bioCERTIFIED™

100 GM

USP, bioCERTIFIED™

DE901

Dexamethasone Sodium Phosphate, USP, bioCERTIFIED™

25 GM

USP, bioCERTIFIED™

E9220

Ethyl Oleate, NF, bioCERTIFIED™

4 LT

NF, bioCERTIFIED™

G9300

Glycerin (Glycerol) Natural, USP, EP, BP, JP, FCC, bioCERTIFIED™

500 ML, 4, 20, 200 (LT)

USP, EP, BP, JP, FCC, bioCERTIFIED™

HY901

Hydroxocobalamin, USP, bioCERTIFIED™

100, 500 (GM), 1 KG

USP, bioCERTIFIED™

KE902

Ketorolac Tromethamine, USP, bioCERTIFIED™

25 GM

USP, bioCERTIFIED™

LA901

Labetalol Hydrochloride, USP, bioCERTIFIED™

100 GM

USP, bioCERTIFIED™

LE913

Levocarnitine, Free Base, USP, bioCERTIFIED™

1, 6.25, 25 (KG)

USP, bioCERTIFIED™

GL902

L-Glutathione, EP, bioCERTIFIED™

100, 250, 500 (GM), 1 KG

EP, bioCERTIFIED ™

H9400

L-Histidine, USP, JP, bioCERTIFIED™

1, 2.5, 12 (KG)

USP, JP, bioCERTIFIED™

VA910

L-Valine, USP, JP, bioCERTIFIED™

1, 2.5, 12, 25 (KG)

USP, JP, bioCERTIFIED™

ME919

Methionine, USP, bioCERTIFIED™

500 GM, 1.25 KG

USP, bioCERTIFIED ™

PH901

Phenylephrine Hydrochloride, USP, bioCERTIFIED™

100 GM, 1, 5 (KG)

USP, bioCERTIFIED™

PO981

Potassium Chloride, EP, USP, bioCERTIFIED™

1, 5 (KG)

EP, USP, bioCERTIFIED™

PR900

Prednisolone Sodium Phosphate, USP, bioCERTIFIED™

100 GM

USP, bioCERTIFIED™

RI914

Riboflavin 5'-Phosphate Sodium, USP, bioCERTIFIED™

250 GM, 12 KG

USP, bioCERTIFIED™

RO902

Ropivacaine Hydrochloride, USP, bioCERTIFIED™

1 KG

USP, bioCERTIFIED™

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About Spectrum Pharmacy Products

Spectrum Pharmacy Products leverages our expertise in sourcing, QC testing and packaging of chemicals provided by other manufacturers to meet the needs of organizations in highly regulated industries.  Spectrum Pharmacy Products is a certified women’s business enterprise (WBE).

Spectrum Pharmacy Products is a division of Spectrum Laboratory Products, Inc. and over 200 employees work together across three worldwide locations to offer thousands of chemicals in laboratory, scale-up and bulk quantities.  We also provide supplies, equipment, consumables, and PPE for your pharmacy.

We conduct in-house QC testing by lot to safeguard quality at each of our facilities and provide extensive regulatory and scientific documentation to ensure compliance. We also offer change control, lot traceability and supply chain transparency to eliminate unpredictability. Our products are packaged and stored under cGMP in FDA-registered and inspected facilities.

With our diverse product portfolio and relentless focus on quality, we deliver security of supply to minimize risk and raw material variability, as well as offer highly personalized service and practical consultations to earn your trust and exceed expectations.

2023