bioCERTIFIED Products

Meet increasing quality, safety and regulatory requirements with confidence with Spectrum Chemical's bioCERTIFIED products. Featuring expanded laboratory testing and documentation, our bioCERTIFIED portfolio is tailored to meet unique manufacturing requirements for pharmaceutical and biopharmaceutical products.

From research and development to scale-up and production, bioCERTIFIED products allow you to simplify, standardize, and streamline your manufacturing processes to ensure success. All bioCERTIFIED chemicals undergo full compendial testing with additional testing for total aerobic microbial count (TAMC), total yeast and mold count (TYMC), residual solvents, elemental impurities validated to USP 232/233, and presence of endotoxins according to the specifications of the compendia or internally set limits. In addition, bioCERTIFIED products are backed by Spectrum Chemical's "100% Tested, 100% Transparent,100% Trusted" guarantee of product performance to the specifications and your satisfaction.

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. We provide comprehensive testing, scientific documentation and customization to meet your requirements, reduce your workload and accelerate biopharmaceutical production.

Full monograph testing for every lot-- to include TAMC, TYMC, elemental impurities and endotoxin according to the specifications of the compendia or internally set limits
Comprehensive technical documentation-- professionally-prepared files succinctly provide documentation for all bioCERTIFIED chemicals
Extensive product breadth and availability-- globally-sourced products include amino acids, biological buffers, inorganic salts, sugars, carbohydrates, cleaning-in-place solutions and more
Scale-up and streamlined speed-to-market support-- flexibility to accommodate different requirements from small, pre-packaged (pilot) to bulk sizes
Industry-leading service-- technical support, dedicated sales advisor support, regulatory, quality management and purchasing teams

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.

Chemical Type	Product Description	Catalog No.	Size Range
Acid	Ascorbic Acid, USP, bioCERTIFIED™	AS922	1, 2.5, 12, 25, 50 KG
Amino Acid	L-Arginine Monohydrochloride, cGMP, USP, EP, JP, bioCERTIFIED™	A9610	1, 2.5, 12, 25, 50 KG
Amino Acid	L-Arginine, Free Base, cGMP, USP, EP, JP, bioCERTIFIED™	A9601	1, 2.5, 12, 25, 50 KG
Amino Acid	L-Arginine, USP, JP, bioCERTIFIED™	A9600	1, 2.5, 12, 50 KG
Amino Acid	L-Asparagine, Monohydrate, FCC, EP, bioCERTIFIED™	A9602	1, 2.5, 12, 25 KG
Amino Acid	L-Glutamine, cGMP, bioCERTIFIED™	G9100	1, 2.5, 12, 25, 50 KG
Amino Acid	L-Histidine Hydrochloride, Monohydrate, JP, bioCERTIFIED™	H9450	1, 2.5, 12, 25 KG
Amino Acid	L-Histidine Monohydrochloride Hydrate, cGMP, Media Grade, JP, bioCERTIFIED™	H9460	1, 2.5, 12, 25, 50 KG
Amino Acid	L-Histidine, Media Grade, bioCERTIFIED™	H9455	1, 2.5, 12, 25, 50 KG
Amino Acid	L-Lysine Monohydrochloride, USP, JP, bioCERTIFIED™	L9800	1, 2.5, 12, 25 KG
Amino Acid	L-Threonine, USP, JP, bioCERTIFIED™	T9400	1, 2.5, 12, 50 KG
Amino Acid	L-Valine, USP, JP, bioCERTIFIED™	V9100	1, 2.5, 12, 25 KG
Biological Buffer	BES, non cGMP, Bioprocess Grade, bioCERTIFIED™	B9215	1, 2.5, 10, 25 KG
Biological Buffer	Bicine, Biological Buffer, Bioprocessing Grade, non-cGMP, Micro and Endotoxin Tested, bioCERTIFIED™	B7200	1, 2.5, 10, 25 KG
Biological Buffer	HEPES, non-cGMP, Bioprocess Grade, Micro and Endotoxin Tested, bioCERTIFIED™	H9210	1, 2.5, 10, 25 KG
Biological Buffer	MES, non-cGMP, Bioprocess Grade, Micro and Endotoxin Tested, bioCERTIFIED™	M9410	1, 2.5, 10, 25 KG
Biological Buffer	MOPS, non-cGMP, Bioprocess Grade, Micro and Endotoxin Tested, bioCERTIFIED™	M9415	1, 2.5, 10, 25 KG
Biological Buffer	MOPSO, Biological Buffer, Bioprocessing Grade, non-cGMP, Micro and Endotoxin Tested, bioCERTIFIED™	M7200	1, 2.5, 10, 25 KG
Biological Buffer	TAPS, Biological Buffer, Bioprocessing Grade, non-cGMP, Micro and Endotoxin Tested, bioCERTIFIED™	T7200	1, 2.5, 10, 25 KG
Biological Buffer	TRICINE, Biological Buffer, Bioprocessing Grade, non-cGMP, Micro and Endotoxin Tested, bioCERTIFIED™	T7210	1, 2.5, 10, 25 KG
Biological Buffer	Tris(hydroxymethyl)aminomethane, USP, EP, BP, bioCERTIFIED™	T9700	1, 2.5, 12, 25, 50 KG
Biological Buffer	Trismat^® Hydrochloride, Non-cGMP, bioCERTIFIED™	T9725	1, 5, 10, 25, 50 KG
Buffering Agent	Acetic Acid, USP, EP, BP, JP, IP, bioCERTIFIED™	A9020	1, 4, 20, 200 LT
Buffering Agent	Citric Acid, Monohydrate, USP, EP, BP, JP, FCC, bioCERTIFIED™	C9400	1, 2.5, 12, 25, 50 KG
Buffering Agent	Citric Acid, USP, EP, BP, JP, bioCERTIFIED™	C9305	1, 2.5, 12, 45 KG
Buffering Agent	Dibasic Sodium Phosphate, Anhydrous, USP, EP, bioCERTIFIED™	S9300	1, 2.5, 10, 50 KG
Buffering Agent	Dibasic Sodium Phosphate, Dodecahydrate, USP, EP, bioCERTIFIED™	S9378	1, 2.5, 10, 50 KG
Buffering Agent	Monobasic Sodium Phosphate, Anhydrous, USP, bioCERTIFIED™	S9377	1, 2.5, 10, 50 KG
Buffering Agent	Monobasic Sodium Phosphate, Dihydrate, USP, EP, bioCERTIFIED™	S9375	1, 2.5, 10, 50 KG
Buffering Agent	Monobasic Sodium Phosphate, Monohydrate, USP, BP, FCC, bioCERTIFIED™	S9404	1, 5 KG
Buffering Agent	Monobasic Sodium Phosphate, Monohydrate, USP, BP, bioCERTIFIED™	S9376	1, 2.5, 10, 50 KG
Buffering Agent	Potassium Acetate, Endotoxin Tested, cGMP, bioCERTIFIED™	P9110	1, 2.5, 10, 50 KG
Buffering Agent	Potassium Acetate, EP, BP, JPE, bioCERTIFIED™	P9813	1, 2.5, 12 ,50 KG
Buffering Agent	Potassium Phosphate Monobasic, NF, EP, bioCERTIFIED™	P9800	1, 2.5, 12, 45 KG
Buffering Agent	Sodium Acetate, Trihydrate, USP, EP, JP, FCC, bioCERTIFIED™	S9000	1, 5, 12, 50 KG
Buffering Agent	Sodium Phosphate Tribasic, Anhydrous, NF, bioCERTIFIED™	S9401	1, 2.5, 10, 50 KG
Buffering Agent	Sodium Phosphate, Dibasic, Dihydrate, USP, EP, bioCERTIFIED™	S9350	1, 2.5, 10, 50 KG
Buffering Agent	tri-Sodium Citrate, Dihydrate, USP, EP, BP, JP, bioCERTIFIED™	S9250	1, 2.5, 12, 25, 50 KG
Cell Culture Aid	Choline Chloride, USP, FCC, Dietary Supplement, bioCERTIFIED™	C9040	1, 12, 25 KG
Cell Culture Aid	Dexamethasone Sodium Phosphate, USP, bioCERTIFIED™	DE901	5, 25 GM
Cell Culture Aid	PEG 400, USP/NF, EP, bioCERTIFIED™	P9070	1, 4, 20, 200 LT
Cell Culture Aid	Potassium L-Glutamate Monohydrate, bioCERTIFIED™	G9710	1, 2.5, 12, 25, 50 KG
Chelator	Edetate Disodium, USP, EP, JP, bioCERTIFIED™	E9600	1, 2.5, 12, 45, 50 KG
Chelator	EDTA di-Sodium Salt, Dihydrate, USP, EP, BP, JP, FCC, ACS, bioCERTIFIED™	E9100	1, 2.5, 12, 45 KG
Inorganic Salt	Calcium Acetate, USP, EP, bioCERTIFIED™	C9001	1, 2.5, 5, 12, 25, 50 KG
pH Adjuster	Hydrochloric Acid Solution, cGMP, 0.1 N, bioCERTIFIED™	H9801	4, 20, 200 LT
pH Adjuster	Hydrochloric Acid Solution, cGMP, 0.5 N, bioCERTIFIED™	H9802	4, 20, 200 LT
pH Adjuster	Hydrochloric Acid Solution, cGMP, 6.0 N, bioCERTIFIED™	H9803	1, 4, 20, 200 LT
pH Adjuster	Sodium Bicarbonate, USP, FCC, bioCERTIFIED™	S9100	1, 5 Kg
pH Adjuster	Sodium Carbonate, Anhydrous, USP, EP, BP, JP, FCC, bioCERTIFIED™	S9150	1, 5 KG
pH Adjuster	Sodium Hydroxide Solution, 0.1 N, bioCERTIFIED™	S9291	5, 25, 200 LT
pH Adjuster	Sodium Hydroxide Solution, 0.5N, bioCERTIFIED™	S9292	5, 25, 200 LT
pH Adjuster	Sodium Hydroxide Solution, 1.0N, bioCERTIFIED™	S9290	5, 25, 200 LT
pH Adjuster / Surfactant (Non-Ionic)	Trolamine 99, NF, bioCERTIFIED™	T9760	1, 4, 20, 200 LT
Preservative	Benzyl Alcohol, NF, EP, BP, JP, bioCERTIFIED™	B8200	500 ML, 1, 4, 25 LT
Preservative	Benzyl Alcohol, Parenteral Grade, NF, bioCERTIFIED™	B8210	500 ML, 4, 25 LT
Preservative	Isopropyl Alcohol, 99 Percent, USP, EP, BP, JP, FCC, ACS, bioCERTIFIED™	I9200	1, 5, 55 GL
Preservative / CIP	Ethyl Alcohol, 18 Percent w/ WFI, Downstream Bioprocess Solution, bioCERTIFIED™	E9210	1, 5, 55 GL
Preservative / CIP	Ethyl Alcohol, 20 Percent w/ WFI, Downstream Bioprocess Solution, bioCERTIFIED™	E9200	1, 5, 55 GL
Preservative / CIP	Glycerin (Glycerol) Natural, USP, EP, BP, JP, FCC, bioCERTIFIED™	G9300	500 ML, 1, 4, 20, 200 LT
Preservative / CIP	Propylene Glycol, USP, EP, JP, FCC, bioCERTIFIED™	P9875	1, 4, 20, 200 LT
Salt	Ammonium Sulfate, USP, ACS, bioCERTIFIED™	AM909	1, 5 KG
Salt	Ammonium Sulfate, USP, ACS, Pyrogen Free, bioCERTIFIED™	A9400	1, 5 KG
Salt	Calcium Chloride, Dihydrate, USP, EP, JP (Pyrogen Free), bioCERTIFIED™	C9000	1, 2.5 KG
Salt	Magnesium Chloride, Hexahydrate, Crystal, USP, EP, BP, JPC, FCC, bioCERTIFIED™	M9100	1, 2.5, 10, 12 KG
Salt	Magnesium Sulfate, Heptahydrate, USP, EP, bioCERTIFIED™	M9701	1, 5, 12, 25 KG
Salt	Potassium Chloride, USP, EP, bioCERTIFIED™	P9811	1, 5 KG
Salt	Sodium Chloride, USP, EP, BP, JP, bioCERTIFIED™	S9200	1, 5, 12, 25, 50 KG
Salt	Sodium Chloride, USP, EP, bioCERTIFIED™	S9210	1, 12, 25, 50 KG
Salt	Sodium Sulfate, Anhydrous, USP, EP, bioCERTIFIED™	S9500	1, 5 KG
Sugar	alpha, alpha-Trehalose, Dihydrate, Low Endotoxin, USP/NF, EP, JP, ChP, bioCERTIFIED™	T9605	1, 2.5, 12, 25, 50 KG
Sugar	Dextrose, Anhydrous, USP, EP, BP, JP, bioCERTIFIED™	D9350	1, 2.5, 12, 50 KG
Sugar	Dextrose, Anhydrous, USP, EP, BP, JP, bioCERTIFIED™	D9300	1, 2.5, 12, 45 KG
Sugar	D-Galactose, Bio-Excipient Grade, (Plant Derived), NF, EP, bioCERTIFIED™	D9200	1, 2.5, 12, 50 KG
Sugar	Lactose, Monohydrate, NF, EP, BP, JP, bioCERTIFIED™	L9010	1, 2.5, 12, 25, 50 KG
Sugar	Sucrose, (Beet Derived), USP/NF, EP, JP, ChP, bioCERTIFIED™	S9160	1, 2.5, 12, 25, 50 KG
Sugar	Sucrose, NF, EP, BP, Endotoxin Tested, bioCERTIFIED™	S9700	1, 2.5, 12, 45 KG
Surfactant / Anionic	Sodium Lauryl Sulfate, NF, EP, BP, JP, bioCERTIFIED™	S9155	1, 2.5, 10, 50 KG
Surfactant / Cationic	Benzalkonium Chloride, NF, EP, BP, Endotoxin Tested, bioCERTIFIED™	B9200	1, 2.5, 10, 50 KG
Surfactant / Non-Ionic	Polysorbate (TWEEN) 20, Vegetable Based, Low Endotoxin, NF, EP, BP, JPE, bioCERTIFIED™	P9310	1, 4, 20, 200 LT
Surfactant / Non-Ionic	Triton^® X-100, bioCERTIFIED™	T9701	1, 4, 20, 200 LT

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