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List of GMP-compliant pharmaceutical raw materials
The GMP pharmaceutical raw materials list is given below and includes products that A&C has developed to solve specific issues for our clients. These products meet a number of monograph requirements or various multi-compendial grades (USP/NF/EP/BP/JP). If a product does not fulfill a specific monograph or multi-compendial grade, or if it does not satisfy your standards,
| SKU | CAS NO | NAME | DESCRIPTION | SDS | PRODUCT SPEC |
|---|---|---|---|---|---|
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P1820214 |
122-99-6 |
2-PHENOXYETHANOL MULTI-COMPENDIAL A&C GRADE |
A&C’s 2-Phenoxyethanol is used as an excipient and meets USP-NF, EP and BP monographs. |
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D18561 |
N/A |
A&C DISSOLUTION MEDIA CONCENTRATE SODIUM PHOSPHATE pH 6.8 |
A&C's Buffer solutions are used as a means of keeping pH at a nearly constant value in a wide variety of chemical applications. Phosphate buffer solutions are commonly used in biopharmaceutical applications. |
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A152 |
67-64-1 |
ACETONE NF |
A&C’s Acetone NF meets the USP-NF monograph. It is a low boiling, volatile organic compound. It is considered one of the five common excipient solvents suitable for pharmaceutical preparations, including water, methanol, dehydrated alcohol and ether. It is used to make drugs and other chemicals and it is also used to dissolve other substances. Acetone has been used in protein crystallization and it is utilized in the manufacturing of various chemicals such as methyl isobutyl ketone, mesityl oxide, diacetone alcohol, acetic acid, iodoform, bromoform, rayon. |
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B1416 |
8001-54-5 |
BENZALKONIUM CHLORIDE 17% USP NF |
A&C’s Benzalkonium Chloride 17% is a preservative which meets the NF monograph. |
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B1415 |
8001-54-5 |
BENZALKONIUM CHLORIDE 50% NF |
A&C’s Benzalkonium Chloride 50% is a preservative which meets the NF monograph. It acts as an quaternary ammonium compound, which is applied as a disinfectant and as a preservative in ophthalmic topical solutions. It is widely used as a preservative in eye drops and in the pharmaceutical industry it is employed as an antimicrobial preservative, antiseptic, disinfectant, solubilizing agent, and wetting agent, burn sprays, skin and wound cleaning. |
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B1690 |
100-51-6 |
BENZYL ALCOHOL MULTI-COMPENDIAL |
A&C’s Benzyl Alcohol multi-compendial is a preservative which meets USP-NF, EP, BP and JP monographs. Benzyl Alcohol has a transparent colourless liquid and slightly aromatic odour. It is slightly soluble in water and it is employed as an antiparasitic agent in parental dosage forms. |
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B3975 |
N/A |
BUFFER SOLUTION PHOSPHATE pH 6.80 |
A&C's Buffer solutions are used as a means of keeping pH at a nearly constant value in a wide variety of chemical applications. Phosphate buffer solutions are commonly used in biopharmaceutical applications. |
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C46297 |
110-82-7 |
CYCLOHEXANE PHARMA GRADE |
A&C's Cyclohexane is used in fungicidal formulations, in recrystallization of steroids and in analytical chemistry for molecular weight determinations. It is also a chemical intermediate in the manufacturing of adipic acid, benzene, cyclohexyl chloride, nitrocyclohexane, cyclohexanol and cyclohexanone. |
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C246901 |
57-09-0 |
Cetrimonium Bromide |
A&C's Cetrimonium Bromide USP-NF is a GMP manufactured excipient meeting the current USP-NF specifications. It is a quaternary ammonium surfactant effective antibacterial agent |
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C34347 |
8001-69-2 |
Cod Liver Oil (1000A/100D) |
A&C's Cod Liver Oil USP-NF meets the current specifications of the USP-NF monograph. It is stored in tightly sealed drums packed under nitrogen. It may be used as a vitamin A and vitamin D source supplement |
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D171270 |
67-68-5 |
DMSO (Dimethyl Sulfoxide |
DMSO is a colorless, odorless liquid, and, more technically - a polar, aprotic solvent. DMSO is a highly versatile material employed in several applications in pharmaceutical and biopharmaceutical drug formulations. |
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F151 |
50-00-0 |
FORMALDEHYDE USP 37% |
A&C's Formaldehyde is used to inactivate bacterial products for toxoid vaccines, (these are vaccines that use an inactive bacterial toxin to produce immunity.) It is also used to kill unwanted viruses and bacteria that might contaminate the vaccine during production. Formaldehyde is removed from the vaccine before it is packaged |
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H2055 |
7647-01-0 |
HYDROCHLORIC ACID NF 10% W/V |
A&C's Hydrochloric Acid NF is used as a low pH neutralizing agent for pharmaceutical applications. It meets the USP-NF monograph specifications |
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P18403 |
329-98-6 |
Phenylmethylsulfonyl Fluoride |
A&C's GMP Phenylmethylsulfonyl Fluoride (PMSF) is an irreversible serine protease inhibitor used for cell lysis, protein isolation and protein extraction. PMSF works via sulfonylation of the serine residue, inhibiting multiple protease enzymes. |
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P25040 |
25322-68-3 |
Polyethylene Glycol 400 (low endotoxin) |
A&C's Polyethylene Glycol 400 USP-NF is a short chain non-ionic surfactant manufactured according to the USP-NF specifications. It is a viscous, colourless short chain and low toxicity polyethylene glycol widely used in pharmaceutical formulations. |
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S3057 |
1310-73-2 |
SODIUM HYDROXIDE NF SOLUTION 50% (W/W) |
A&C's Sodium Hydroxide is a highly caustic concentrate solution (high pH) typically used for cleaning purposes. It is especially effective at stripping organic residues from stainless steel equipment. It is prepared from solid NaOH pellets and purified water that meet the respective USP-NF monograph specifications |
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S3246 |
7681-52-9 |
SODIUM HYPOCHLORITE 5% USP SOLUTION |
A&C’s Sodium Hypochlorite 5% USP solution meets the USP specification requirements and is used for cleaning and disinfecting. |
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T10229 |
54-64-8 |
THIMEROSAL USP |
A&C’s Thimerosal USP is a preservative which meets the USP-NF monographs. It presents as a white to off-white crystalline powder. It is applied in many medical applications of skin test antigens, drug preservatives, antivenins, and ophthalmic and nasal products. It is employed as a preservative in vaccines and antibiotics. |
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T102291 |
54-64-8 |
THIMEROSAL USP 10% (W/V) AQUEOUS SOLUTION |
A&C’s Thimerosal USP 10% aqueous solution is a preservative that meets the USP monograph. Thiomersal's main use is as an antiseptic and antifungal agent. In multidose injectable drugs, it prevents serious adverse effects such as the Staphylococcus infection |
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T15550 |
108-88-3 |
TOLUENE PHARMA GRADE |
A&C's Toluene is a homologue of benzene, also known as "methyl benzene" and "phenyl methane." It is a colourless with a special aroma. It is used in production of drugs of abuse. It is used in the production of pharmaceuticals, dyes, and cosmetic nail products. It is used against roundworms and hookworms |
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T1553 |
108-88-3 |
TOLUENE PHARMA GRADE LOW BENZENE <25 PPM |
A&C's Toluene reagent low benzene is a solvent controlled and tested to have very low benzene impurity |
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BUFFERS, PROCESS SOLUTIONS AND CLEANING SOLUTIONS
A&C has a lengthy history of providing cleaning solutions, process solutions, and GMP buffers to the pharmaceutical and biopharmaceutical sectors. Furthermore, we may provide our clients with buffering salts and concentrates to be mixed in-house with USP water or WFI (Water for Injection).
Most production steps require buffers, and A&C recognizes that the success of our clients’ pharmaceutical and biopharmaceutical operations depends on the quality of their buffers. We use USP WFI and USP filtered water for the production of our buffers.
We have a specialized, cutting-edge facility in Europe called A&C Bio Buffer for buffer manufacturing in addition to our factories in North America. A&C Bio Buffer offers a spectrum of GMP buffers and chemical blends, as well as custom blends and solutions or dilutions prepared under GMP guidelines. A&C is able to provide goods tailored to the needs of its customers because to its state-of-the-art GMP manufacturing facility, reliable quality management systems, production proficiency, and technical superiority. This enables our clients to contract with A&C, the ideal worldwide GMP partner for custom buffers and custom chemical blends, to handle the production of their process solutions, cleaning solutions, and buffers.
PRESERVATIVES
GMP preservatives are produced by A&C for the life sciences sector. They stop the chemical deterioration and microbial growth in the final medication formulation. High water solubility and stability and efficacy across a broad pH and temperature range are characteristics of A&C GMP preservatives. Some of our commercially available preservatives in different compendia are listed above. If necessary, complete supporting documentation can be supplied for each of these products.
SOLVENTS
A&C produces a range of GMP solvents with high purity for use in the pharmaceutical and biopharmaceutical industries. Because of the purity, control, transparency, and documentation that our solvents offer, our customers employ them. Many medical goods, including topical ointments, aspirin, cough syrup, and penicillin, are formulated with the help of solvents. Additionally, we can offer a large selection of solvents in unique packaging to suit your requirements. If obtaining GMP solvent is necessary,
