Pharma Secondary Standards

Pharmaceutical Secondary Standards Certificate of Analysis Tracking

From time to time, the Compendial Lots that these Secondary Standards are made traceable to change. This necessitates a requalification of the Secondary Standard Lot against the current lot of Compendial reference standards or substances and a subsequent update to the Certificate of Analysis. The Secondary Standard portfolio is being updated continually with new products and replacement batches of existing products. The latest Secondary Standard information can be found below. For more details, visit Secondary Standards for Pharmaceutical Quality Control.

Updated COAs can be found by following the material link in the table and entering the batch in the appropriate location.

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COAs for the following products have been updated

Part Number Description Lot #'s Type of Change Date Issued
PHR1152-1G Phenyl Salicylate Melting Point Standard LRAA7176 Correcting lot number in page 2 8 October 2018
PHR1632-500MG Pioglitazone Hydrochloride LRAB3624 Update CRM Expirtion to 12/31/2021 16 October 2018
PHR1081-10G Octinoxate LRAB3324 Correct expiration date  23 October 2018
PHR1059-1G Omeprazole P500059/LRAA7136 Requal vs. USP R065N0; EP 5.0 31 October 2018
PHR1059-1G Omeprazole LRAB0280 Requal vs. BP 3840 31 October 2018
PHR1063-3X1.2ML Residual Solvents - Class I Mix LRAA0990/LRAA8973/LRAB3312 Requal vs. USP R053P0 31 October 2018
PHR1100-1G L-Phenylalanine P500100/LRAA7164/LRAB9001 Requal vs. EP 5.0 31 October 2018
PHR1197-500MG Iminostilbene P500197/LRAA9013 Requal vs. USP R058H0 31 October 2018
PHR1241-1G Methionine P500241/LRAA9045 Requal vs. USP R056J0 31 October 2018
PHR1504-500MG Liothyronine LRAB0433 Requal vs. USP R069P0 31 October 2018
PHR1518-1G Polydimethylsiloxane LRAA3325 Requal vs. USP R067P0 31 October 2018
PHR1528-200MG Oxaliplatin LRAA3646/LRAB3831 Requal vs. EP 5.0 31 October 2018
PHR1536-200MG Norphenylephrine Hydrochloride LRAA3654/LRAB9974 Requal vs. USP R069W0 31 October 2018
PHR1551-3X1.2ML Acetonitrile LRAA4467/LRAB0293 Requal vs. USP R046M0 31 October 2018
PHR1579-500MG Ursodiol LRAA4495/LRAB5519 Requal vs. USP R058U0 31 October 2018
PHR1642-50MG N-(4-Hydroxyphenyl)Propanamide (Acetaminophen Related Compound B) LRAA6384/LRAB0954 Requal vs. USP R066W0 31 October 2018
PHR1650-30MG Omeprazole Related Compound I LRAA5497 Requal vs. USP R074M0 31 October 2018
PHR1663-1ML Propofol LRAA5999 Requal vs. USP R046S0; EP 7.0 31 October 2018
PHR1669-100MG 2,6-Dimethylaniline (Lidocaine RCA) LRAA6005/LRAB1757/LRAB7758 Requal vs. EP 2.0 31 October 2018
PHR1783-500MG Anastrozole LRAA8725 Requal vs. USP R079X0 31 October 2018
PHR1836-500MG Naphazoline Hydrochloride LRAB0090 Requal vs. USP M1K405 31 October 2018
PHR2004-50MG Chlorpheniramine Impurity A LRAB4751 Requal vs. EP 5.0 31 October 2018
PHR1470-500MG Scopolamine Hydrobromide LRAB7821 Change security setting and allow to print 2 November 2018
PHR1496-500MG Paromomycin Sulfate LRAB4098/LRAA3044 CoA Correction 8 November 2018
PHR1096-1G L-Lysine Acetate LRAB8916 Update CRM Expirtion Date 12 November 2018
PHR1060-1G Mezilamine LRAB8917 Update CRM Expirtion Date 12 November 2018
PHR1031-500MG α-Tocopherol LRAA7704 Expires 30 November 2018 14 November 2018
PHR1765-1G Cycloserine LRAA8432 Update USP Traceability Statement 14 November 2018
PHR1373-5X1.2ML Alcohol LRAA1629/LRAB6749 Update USP Traceability Statement 14 November 2018
PHR1970-100MG Acetaminophen Impurity C LRAB2775 CoA Correction: Update HPLC Impurities 16 November 2018
PHR1732-4X250MG Vancomycin hydrochloride LRAB3620 Add Mass Balance 19 November 2018
PHR1306-500MG 3-tert-butyl-4-hydroxyanisole LRAA0066/LRAA9102 CoA Correction: Update Package Size 20 November 2018
PHR1008-10G Ascorbic Acid LRAB3631/LRAA9813 Requal vs. USP Y06390; BP 3988 30 November 2018
PHR1008-2G Ascorbic Acid LRAA9724 Requal vs. USP Y06390; BP 3988 30 November 2018
PHR1031-500MG α-Tocopherol LRAB3718 Requal vs. USP R094X0 30 November 2018
PHR1052-1G Metronidazole P500052 Requal vs. EP 3.0 30 November 2018
PHR1079-1G Tobramycin P500079/LRAA5713/LRAB8291/LRAC0046 Requal vs. USP R08010 30 November 2018
PHR1101-1G L-Lysine Hydrochloride P500101/LRAA7137/LRAC0634 Requal vs. EP 4.0 30 November 2018
PHR1139-1G Phenytoin P500169/LRAA8984/LRAB7779 Requal vs. EP 2.0 30 November 2018
PHR1146-500MG 4-Isobutylacetophenone (Ibuprofen Related Compound C) LRAA2744/LRAB2151 Requal vs. USP R06930 30 November 2018
PHR1248-500MG Maltitol P500248/LRAA9052/LRAB7670 Requal vs. EP 5.0 30 November 2018
PHR1270-1G Fumaric Acid LRAA0006/LRAB3115 Requal vs. USP R05520 30 November 2018
PHR1362-5G Calcium Acetate LRAA1466/LRAA9155 Requal vs. USP R077Y0 30 November 2018
PHR1368-100MG 2,3-Dichlorobenzoic acid (Lamotrigine Related Compound B) LRAA1472/LRAA9159 Requal vs. USP R069M0 30 November 2018
PHR1380-1G Ivermectin LRAA1636 Requal vs. USP R091C0; EP 3.0 30 November 2018
PHR1414-1G Methyl Stearate LRAB2971 Requal vs. EP 4.0 30 November 2018
PHR1416-1G Sodium Citrate LRAA2480/LRAA9198/LRAB3326 Requal vs. USP R086N0 30 November 2018
PHR1431-1G Clopidogrel Bisulfate LRAA2739/LRAB3896 Requal vs. EP 2.0 30 November 2018
PHR1554-3X1.2ML Heptane LRAA4470/LRAB3684 Requal vs. USP R052R0 30 November 2018
PHR1594-1G Methacycline Hydrochloride LRAA4710 Requal vs. USP R069B0; BP 3807 30 November 2018
PHR1606-1G Hydrocortisone Acetate LRAA4722/LRAB3722 Requal vs. EP 10.0 30 November 2018
PHR1738-40MG 6-(butylamino)-N-(2,6-dimethylphenyl)hexanamide (Bupivacaine Impurity E) New USP ordered 26 Oct 2018 LRAA7909 Requal vs. USP F1F145; EP 4.0 30 November 2018
PHR1769-1G Isomalt LRAB3698 Requal vs. USP R05510 30 November 2018
PHR1797-1G Imipramine Hydrochloride LRAA8623 Requal vs. USP R061T0; EP 3.0 30 November 2018
PHR1277-500MG Nitrilotriacetic acid LRAA0013/LRAA9074 Requal vs. USP F1I315 30 November 2018
PHR1398-1G Betamethasone LRAA2174/LRAA9184 Requal vs. USP R075L0; EP 6.0 30 November 2018
PHR1153-1G Triethyl Citrate P500153/LRAA8988 Requal vs. USP R07270 30 November 2018
PHR1794-500MG Hesperidin LRAA8621 Requal vs. USP R09140 30 November 2018
PHR1151-1G Theophylline Melting Point Standard P500151/LRAA7175 Requal vs. USP F2M305 30 November 2018
PHR1095-1G Caffeine Melting Point Standard LRAA5826/LRAB0976/P500095 Requal vs. USP R087D0 30 November 2018

 

The following new products were qualified and will be available soon

Part Number Description Lot #
PHR2006-50MG Allopurinol Related Compound B LRAB7872
PHR1644-1G Ferrous Lactate LRAA5305
PHR1461-1G Copper Chlorphyllin LRAA3009
PHR1541-1G Leucovorin Calcium LRAC0039
PHR2019-20MG Candesartan Cilexetil Related Compound D LRAB6057
PHR2022-20MG Candesartan Cilexetil Impurity I LRAB8555
PHR2035-20MG Candesartan Cilexetil Impurity C LRAB8554
PHR1926-500MG Hydrocortisone Hemisuccinate LRAB8580
PHR2097-500MG Betahistine Hydrochloride LRAB8609
PHR2071-50MG Pyrantel Related Compound A LRAB9055
PHR2082-50MG Pyrantel Impurity B LRAB9057
PHR2083-50MG Pyrantel Impurity C LRAB9058
PHR2027-250MG Testosterone LRAB5324
PHR2028-500MG Testosterone Propionate LRAB5325
PHR2084-50MG Pyrantel Impurity D LRAB9059
PHR2079-50MG Risedronate Impurity D LRAB8929
PHR2078-50MG Risedronate Impurity C LRAB8928
PHR2044-1G Mannose LRAB8494
PHR2075-50MG Risedronate Related Compound A LRAB8926
PHR2063-300MG Ambroxol Hydrochloride LRAB8553
PHR2077-50MG Risedronate Related Compound C LRAB8927
PHR2099-1G Cefotaxime Sodium LRAB9060
PHR1374-1G Ethylcelluloe LRAA1630

 

The following new batches of existing products were qualified and will be available soon

Part Number Description Lot #
PHR1689-200MG Ammonium Glycyrrhizate LRAC0910
PHR1371-5ML Benzalkonium Chloride 10% Solution LRAB7817
PHR1802-300MG Naloxone LRAC0029
PHR1518-1G Polydimethylsiloxane LRAB7823
PHR1778-1G Tolnaftate LRAB7857
PHR1620-1G Fluvastatin Sodium LRAC1079
PHR1551-3X1.2ML Acetonitrile LRAB7855
PHR1604-1G Pantoprazole Sodium LRAB7814
PHR1381-1G Aspartame LRAB9987
PHR1513-500MG Enrofloxacin LRAC0027
PHR1149-1G 4-Chloroacetanilide LRAC0397
PHR1834-200MG Itraconazole LRAC0395
PHR1537-1G Oxytetracycline LRAC0364
PHR1545-1G Chlorobutanol LRAB7819
PHR1857-1G Sitagliptin Phosphate LRAC0251
PHR1366-1G Dibutyl Phthalate LRAC1230
PHR1651-30MG Fluconazole Related Compound A LRAC1231
PHR1517-500MG Dihydrostreptomycin Sulfate LRAB9924
PHR1642-50MG N-(4-Hydroxyphenyl)Propanamide (Acetaminophen RCB) LRAC0573
PHR1580-1G Lauric Acid LRAC0576
PHR1553-3X1.2ML Diemthylformamide LRAC0593
PHR1243-500MG Guanine LRAC0250
PHR1609-10G Sodium Dehydroacetic Acid LRAC0572
PHR1630-1G Prednisolone Acetate LRAC0028
PHR1004-1G Ibuprofen LRAC0253
PHR1008-2G Ascorbic Acid LRAB9938
PHR1666-1.2ML Diethyl Ether LRAC0145
PHR1090-1G Dopamine Hydrochloride LRAC1333
PHR1731-1G Nitisinone LRAC0575
PHR1769-1G Isomalt LRAC0143
PHR1576-500MG Pyrazinamide LRAC1435
PHR1237-500MG Cholecalciferol (Vitamin D3) LRAC0270
PHR1798-250MG Levamisole Hydrochloride LRAC0396
PHR1238-100MG Ergocalciferol LRAB7854
PHR1111-1G Glycine LRAC1458
PHR1122-1.5G Phenylethyl Alcohol LRAC1472
PHR1723-400MG Desipramine Hydrochloride LRAC1473
PHR1829-500MG Hypromellose LRAC0715
PHR1654-1G Amikacin LRAB9944
PHR1159-1G Clindamycin Hydrochloride LRAB7830
PHR1554-3X1.2ML Heptane LRAC0594
PHR1106-1G L-Arginine LRAC1487
PHR1602-1G Losartan Potassium LRAC0141
PHR1784-500MG Aripiprazole LRAC0259
PHR1885-500MG Linezolid LRAC0768
PHR1155-1G Octyldodecanol LRAC1506
PHR1547-3X1.2ML Mesityl Oxide LRAC0583
PHR1809-150MG Tacrolimus LRAC1117