Pharmaceutical Impurities

Impurities can significantly impact the efficacy and safety of drug products. Accurate detection and control of impurities in drug substances and drug products is an important element of Quality by Design, ICH and GMP requirements. During manufacture of a drug material impurities can arise from many different sources including drug substance residual impurities, degradation, extractables and leachables, as well as impurities present in or derived from excipients. Typically, Pharmacopoeial Monographs identify multiple impurities for a given drug substance that require each impurity to be analytically verified by a chromatographic method. Multiple sample preparations are usually required, the process can be a time consuming burden and offer significant opportunity for increased uncertainty and error in the analysis. With our pharmaceutical impurity solution mixes we do offer a time efficient, accurate and reproducible way for pharmaceutical analysis.

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A-165   Acetaminophen Impurity Mixture Additional solution 25 μg/mL in methanol (each analyte), certified reference material, ampule of 1 mL, Cerilliant®
A-134   Acetaminophen (Paracetamol) Impurity Mixture solution 25 μg/mL in methanol (each component), certified reference material, ampule of 1 mL, Cerilliant®
A-135 4′-Acetoxyacetanilide (Acetaminophen RCA) solution 250 μg/mL in acetonitrile, certified reference material, ampule of 1 mL, Cerilliant®
A-155 Acetylsalicylic Anhydride (Aspirin Impurity F) solution 100 μg/mL in acetonitrile, certified reference material, ampule of 1 mL, Cerilliant®
C-194   6-Amino-1,3-dimethyl-5-(formylamino) uracil (Caffeine Imp B) solution 40 μg/mL (50:50 ACN:Water), certified reference material, ampule of 1 mL, Cerilliant®
A-136 4-Aminophenol 250 μg/mL in acetonitrile, certified reference material, ampule of 1 mL, Cerilliant®
A-143   Aspirin Impurity Mixture solution 100 μg/mL in acetonitrile (each analyte), certified reference material, ampule of 1 mL, Cerilliant®
A-151   Atorvastatin Impurity Mixture solution certified reference material, ampule of 1 mL, Cerilliant®
B-082   Bupropion Impurity Mixture solution 100 μg/mL in methanol (each analyte), certified reference material, ampule of 1 mL, Cerilliant®
B-069   Bupropion System Suitability Mix solution 12-20 μg/mL (80:20 0.001N HCl:Methanol), certified reference material, ampule of 1 mL, Cerilliant®
C-175   Caffeine Impurity Mixture solution 0.04-2.0 mg/mL (50:50 Acetonitrile:Water (v/v)), certified reference material, ampule of 1 mL, Cerilliant®
C-195 Caffeine Impurity E Nitrate solution 100 μg/mL in methanol, certified reference material, ampule of 1 mL, Cerilliant®
C-166 4-Chloroacetanilide (Acetaminophen RCJ) hydrochloride solution 250 μg/mL in acetonitrile, certified reference material, ampule of 1 mL, Cerilliant®
C-197 Chlorpheniramine Impurity C solution 50 μg/mL in acetonitrile, certified reference material, ampule of 1 mL, Cerilliant®
C-193   Chlorpheniramine Impurity Mixture solution certified reference material, ampule of 1 mL, Cerilliant®
M-196 Cyanoguanidine (Metformin Related Compound A) solution 50 μg/mL in methanol, certified reference material, ampule of 1 mL, Cerilliant®
F-051   Fluconazole Impurity Mixture solution 10 μg/mL (80:20 Water: Acetonitrile, each analyte), certified reference material, ampule of 1 mL, Cerilliant®
F-061   Fluticasone Impurity Mixture solution 20 μg/mL (0.05% H3PO4 in Acetonitrile, (each analyte)), certified reference material, ampule of 1 mL, Cerilliant®
F-052   Furosemide Impurity Mixture solution 5 μg/mL (50:50 Acetonitrile:Water, each analyte), certified reference material, ampule of 1 mL, Cerilliant®
G-022   Guaifenesin Impurity Mixture solution 0.5-1.0 mg/mL in acetonitrile (each analyte), certified reference material, ampule of 1 mL, Cerilliant®
I-036   Ibuprofen Impurity Mixture solution 25 μg/mL in acetonitrile (each component), certified reference material, ampule of 1 mL, Cerilliant®
I-037 Ibuprofen Impurity B (PhEur) solution 100 μg/mL in acetonitrile: water (9:1) (as free acid), certified reference material, ampule of 1 mL, Cerilliant®
L-048   Lidocaine Impurity Mixture solution 20-200 μg/mL in acetonitrile (each analyte), certified reference material, ampule of 1 mL, Cerilliant®
M-195   Metformin Impurity Mixture hydrochloride solution 50 μg/mL in methanol (each component), certified reference material, ampule of 1 mL, Cerilliant®
N-116   Nevirapine Impurity Mixture solution 15-30 μg/mL (80:20 25 mM NH4H2PO4 (pH 5):Acetonitrile), certified reference material, ampule of 1 mL, Cerilliant®
O-048   Omeprazole Impurity Mixture solution 60 μg/mL in acetonitrile (each component), certified reference material, ampule of 1 mL, Cerilliant®
P-125   Parabens Impurity Mixture solution 50 μg/mL in acetonitrile (each analyte), certified reference material, ampule of 1 mL, Cerilliant®
P-140   Pramipexole Chiral System Suitability Solution solution 10 μg/mL (85:15:0.1 Hexane:Ethanol:DEA), certified reference material, ampule of 1 mL, Cerilliant®
P-141   Pramipexole Organic Impurity System Suitability Mixture solution certified reference material, ampule of 1 mL, Cerilliant®
P-126   Pyridoxine Impurity Mixture solution 50 μg/mL in methanol: water (1:1) (each analyte), certified reference material, ampule of 1 mL, Cerilliant®
R-029   Riboflavin Impurity Mixture solution 90 μg/mL in water, certified reference material, ampule of 1 mL, Cerilliant®
R-030   Rivastigmine Impurity Mixture solution 100 μg/mL in methanol (each analyte), certified reference material, ampule of 1 mL, Cerilliant®
S-100   Salicylic Acid Impurity Mixture solution 10-500 μg/mL (MeOH:Water:Acetic Acid (70:30:4)), certified reference material, ampule of 1 mL, Cerilliant®
T-134   Thiamine Impurity Mixture solution 100 μg/mL (Methanol:1% Acetic Acid 50:50, each analyte), certified reference material, ampule of 1 mL, Cerilliant®