100% Tested. 100% Transparent.  100% Trusted.
bioCERTIFIED™ Products for Biopharmaceutical Manufacturing

Meet increasing quality, safety and regulatory requirements with confidence with Spectrum Chemical's bioCERTIFIED™ Quality Management System and products for biopharmaceutical manufacturing.

Featuring expanded laboratory testing, certifications and documentation, our bioCERTIFIED portfolio is tailored to each customer’s unique requirements from biopharmaceutical drug discovery to pilot and scale-up to production.

bioCERTIFIED products help you simplify, standardize and streamline bioprocessing to ensure success and speed time to market. And they are backed by Spectrum Chemical'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.

For parenteral applications in which a biological drug enters directly into the bloodstream, even more stringency is required to ensure a product is endotoxin-free with minimal bioburden. New USP 232/233 requirements for elemental impurities put even more demand on the certifications for raw materials. bioCERTIFIED products have undergone additional testing for bioburden, endotoxin and elemental impurities.

Spectrum Chemical's extensive knowledge and experience in the changing global environment 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 Chemical 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 and accelerate biopharmaceutical production.

 

  • 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.
  • Modern ISO Class 8 certified clean packaging facilities
  • 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.
  • Auditing and quality management controls — Suppliers and processes are regularly audited; corrective and preventive actions (CAPAs) are quickly addressed.

Catalog No.

Product Description

Size Range

Grade

B8200

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

1, 4, 25 (Liters)

NF, EP, BP, JP, cGMP

B8210

Benzyl Alcohol, Parenteral, NF bioCERTIFIED™

1, 4, 25, 200L

Parenteral Grade, NF

C9001

Calcium Acetate USP, EP bioCERTIFIED™

1, 5, 12, 25, 50 KG

USP, EP

D9300

Dextrose (Glucose) Anhydrous USP, EP, BP, JP bioCERTIFIED™

1, 2.5, 12, 50KG

USP, EP, BP, JP

E9200

Ethyl Alcohol, 20 Percent w/ WFI, Downstream Bioprocess Solution, bioCERTIFIED™

1, 5, 55 Gallons

cGMP Manufactured

E9200

Ethanol (EtOH) 20% w/ WFI, Downstream Bioprocess Solution bioCERTIFIED™

1, 5, 55 GAL

Downstream Bioprocess Solution

G9300

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

4, 20, 200 Liters

USP, EP, BP, JP, FCC, cGMP

H9801

Hydrochloric Acid Solution, 0.1 N, bioCERTIFIED™

4, 20, 200 (L)

cGMP

H9802

Hydrochloric Acid Solution, 0.5 N Solution, NF, EP, bioCERTIFIED™

4, 20, 200 (L)

cGMP

H9803

Hydrochloric Acid Solution, 6.0 N Solution, NF, EP, bioCERTIFIED™

4, 20, 200 (L)

cGMP

H9450

L-Histidine Monochloride Monohydrate, cGMP

1, 2.5, 12, 25 (KG)

USP, EP, JP, cGMP

L9800

L-Lysine Monochloride Monohydrate, cGMP

1, 12 (KG)

USP, EP, JP, cGMP

T9400

L-Threonine, USP, JP, bioCERTIFIED™

1, 12 (KG)

USP, JP, cGMP

V9100

L-Valine, USP, JP, bioCERTIFIED™

1, 12 (KG)

USP, JP, cGMP

M9701

Magnesium Suflafate Heptahydrate USP, EP bioCERTIFIED™

1, 5, 12, 25 KG

USP, EP

P9810

Potassium Acetate, cGMP, Endotoxin Tested

1, 2.5, 12, 45 (KG)

USP, EP, cGMP

P9813

Potassium Acetate EP, BP, JPE bioCERTIFIED™

1, 2.5, 12, 50KG

EP,BP, JPE

S9160

Sucrose Beet Derived, USP/NF, EP, JP, ChP, Low Endotoxin 1, 2.5, 12, 25, 50KG USP/NF, EP, JP, ChP

S9210

Sodium Chloride USP, EP bioCERTIFIED™

12, 25 KG

USP, EP

S9291

Sodium Hydroxide Solution, 0.1 N, bioCERTIFIED™

500ML, 5, 25, 200 (LT)

cGMP

S9292

Sodium Hydroxide Solution, 0.5N, bioCERTIFIED™

500ML, 5, 25, 200 (LT)

cGMP

S9290

Sodium Hydroxide Solution, 1.0N, bioCERTIFIED™

500ML, 5, 25, 200 (LT)

cGMP

S9377

Monobasic Sodium Phosphate, Anhydrous, USP, bioCERTIFIED™

1, 2.5, 10, 25, 50 KG

USP

S9404

Monobasic Sodium Phosphate, Monohydrate, USP, BP, FCC, bioCERTIFIED™

1, 5 KG

USP, BP, FCC

S9160

Sucrose, (Beet Derived), USP/NF, EP, JP, ChP bioCERTIFIED™

1, 2.5, 12, 25, 50 KG

USP/NF, EP, JP, ChP

T9700

Tris(hydroxymethyl)aminomethane, USP, EP, BP, bioCERTIFIED™

1, 2.5, 12, 23 (KG)

USP, EP, cGMP

T9605

Trehalose Dihydrate USP/NF, EP, JP, ChP, Low Endotoxin 1, 2.5, 12, 25, 50 KG USP/NF, EP, JP, ChP

T9760

Trolamine 99, NF, bioCERTIFIED™

1, 4, 20, 200L

NF

Catalog No.

Product Description

Size Range

Grade

B8200

Benzyl Alcohol, cGMP

1, 4, 25 (Liters)

NF, EP, BP, JP, cGMP

B8210

Benzyl Alcohol, Parenteral, NF bioCERTIFIED™

1, 4, 25, 200L

Parenteral Grade, NF

C9001

Calcium Acetate USP, EP bioCERTIFIED™

1, 5, 12, 25, 50 KG

USP, EP

D9300

Dextrose (Glucose) Anhydrous USP, EP, BP, JP bioCERTIFIED™

1, 2.5, 12, 50KG

USP, EP, BP, JP

E9200

Ethanol 20%, cGMP

1, 5, 55 Gallons

cGMP Manufactured

E9200

Ethanol (EtOH) 20% w/ WFI, Downstream Bioprocess Solution bioCERTIFIED™

1, 5, 55 GAL

Downstream Bioprocess Solution

G9300

Glycerin, cGMP

4, 20, 200 Liters

USP, EP, BP, JP, FCC, cGMP

H9801

Hydrochloric Acid Solution, 0.1N, cGMP

4, 20, 200 (L)

cGMP

H9802

Hydrochloric Acid Solution, 0.5N, cGMP

4, 20, 200 (L)

cGMP

H9803

Hydrochloric Acid Solution, 6.0N, cGMP

4, 20, 200 (L)

cGMP

H9450

L-Histidine Monochloride Monohydrate, cGMP

1, 2.5, 12, 25 (KG)

USP, EP, JP, cGMP

L9800

L-Lysine Monochloride Monohydrate, cGMP

1, 12 (KG)

USP, EP, JP, cGMP

T9400

L-Threonine, cGMP

1, 12 (KG)

USP, JP, cGMP

V9100

L-Valine, cGMP

1, 12 (KG)

USP, JP, cGMP

M9701

Magnesium Suflafate Heptahydrate USP, EP bioCERTIFIED™

1, 5, 12, 25 KG

USP, EP

P9810

Potassium Acetate, cGMP, Endotoxin Tested

1, 2.5, 12, 45 (KG)

USP, EP, cGMP

P9813

Potassium Acetate EP, BP, JPE bioCERTIFIED™

1, 2.5, 12, 50KG

EP,BP, JPE

S9210

Sodium Chloride USP, EP bioCERTIFIED™

12, 25 KG

USP, EP

S9291

Sodium Hydroxide Solution, 0.1N, cGMP

500ML, 5, 25, 200 (LT)

cGMP

S9292

Sodium Hydroxide Solution, 0.5N, cGMP

500ML, 5, 25, 200 (LT)

cGMP

S9290

Sodium Hydroxide Solution, 1.0N, cGMP

500ML, 5, 25, 200 (LT)

cGMP

S9377

Sodium Phosphate Monobasic Anhydrous USP bioCERTIFIED™

1, 2.5, 10, 25, 50 KG

USP

S9404

Sodium Phosphate Monobasic Monohydrate USP, BP FCC bioCERTIFIED™

1, 5 KG

USP, BP, FCC

S9160

Sucrose (Beet Derived) USP/NF, EP, JP, ChP Low Endotoxin bioCERTIFIED™

1, 2.5, 12, 25, 50 KG

USP/NF, EP, JP, ChP

T9700

TRIS Base (Tromethamine), cGMP

1, 2.5, 12, 23 (KG)

USP, EP, cGMP

T9760

Trolamine 99, NF (Triethanolamine) NF bioCERTIFIED™

1, 4, 20, 200L

NF


Professional Scientific Documentation

As part of Spectrum's expanded bioCERTIFIED™ program, the company offers hundreds of professionally prepared dossiers. Providing such documentation on pilot, scale-up and roduction chemicals mitigates downstream financial risks for biomanufacturers by avoiding costly downtime.

 

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Spectrum has been serving compounders and scientists for nearly five decades, and we've earned the trust of quality-driven industries by continually investing in our infrastructure, instrumentation, regulatory compliance and personnel. We know that our chemical products are only as good as the analytical tests and documentation prove them to be. We perform more than 20,000 analytical tests per year in our 4 globally-located analytical laboratories. Spectrum has been a privately-owned business since 1971, treating our employees and customers as part of the Spectrum family all along. Through this dedication, we have earned the trust of tens of thousands of loyal customers. Spectrum understands the cost concerns of our customers and is committed to providing the highest quality of products and the most competitive prices to our quality-driven customers.