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
PHR1964-50MG Ibuprofen Related Compound F LRAB2590 Correct Structure 11 September 2018
PHR1204-1G Benzophenone LRAA9018/P500204 CoA Update: HPLC Impurity Method 11 September 2018
PHR1018-500MG Dextromethorphan Hydrochloride LRAA9503 Update USP Assay value and HPLC method 22 September 2018
PHR1793-500MG Fluvoxamine Maleate LRAA8815 Requal vs. USP G1L125 30 September 2018
PHR1340-500MG Pyrilamine maleate (Mepyramine) LRAA1092 Requal vs. USP R08220 30 September 2018
PHR1798-250MG Levamisole Hydrochloride LRAA8624 Requal vs. EP 2.0 30 September 2018
PHR1780-1G Betamethasone Valerate LRAA8501 Requal vs. EP 4.0 30 September 2018
PHR1630-1G Prednisolone Acetate LRAA5297 Requal vs. USP R055L0 30 September 2018
PHR1424-1G Ampicillin Sodium LRAA2732/LRAA9206 Requal vs. EP 6.0 30 September 2018
PHR1310-1G Benzene LRAB1529/LRAB5022/LRAA5309 Requal vs. USP R07930 30 September 2018
PHR1091-1G Vanillin Melting Point Standard LRAA6135 Correcting lot number in page 2 30 September 2018
PHR1911-300MG Azacitidine LRAB1224 Correcting Storage to Room Temperature 30 September 2018
PHR1921-500MG Clobetasol Propionate LRAB1226 Requal vs. USP R071T0 30 September 2018
PHR1826-20MG 1,1'-(1,3-Phenylene)-di-(1H-1,2,4-Triazole) (Fluconazole RCC) LRAA9809 Requal vs. USP R061Y0 30 September 2018
PHR1855-500MG Telmisartan LRAB0136 Requal vs. USP R085R0 30 September 2018
PHR1237-500MG Cholecalciferol (Vitamin D3) LRAB2929/LRAA7908 Requal vs. USP R07150; EP 10.0 30 September 2018
PHR1857-1G Sitagliptin Phosphate LRAB0033 Requal vs. USP R07630 30 September 2018
PHR1614-1G Norfloxacin LRAA4873 Requal vs. USP R061R0 30 September 2018
PHR1720-1G Clomipramine Hydrochloride LRAA7394 Requal vs. USP R07670 30 September 2018
PHR1785-500MG Aztreonam LRAA9807 Requal vs. USP R08590 30 September 2018
PHR1339-500MG 3-Amino-1-propanol LRAA1091/LRAA9133 Requal vs. USP R07260 30 September 2018
PHR1185-1G Amlodipine Besylate LRAB1220/P500185/LRAA9004 Requal vs. USP R09060; EP 5.0 30 September 2018
PHR1605-1G Colistin Sulfate LRAA3703 Requal vs. EP 3.0 30 September 2018
PHR1773-100MG Ranitidine Related Compound A LRAA8549 Requal vs. USP R06290 30 September 2018
PHR1824-50MG (R)-2-Amino-4,5,6,7-tetrahydro-6-(propylamino)benzothiazole dihydrochloride (Pramipexole Related Compound D) LRAA9409 Requal vs. USP R073C0 30 September 2018
PHR1472-1G Tartaric Acid LRAB3726 Update CRM Expirtion to 12/31/2022 30 September 2018
PHR1232-500MG Calcium D-pantothenate LRAA8436/LRAB3618 Requal vs. USP R10000 30 September 2018
PHR1546-500MG Acetylcholine chloride LRAB0912 Requal vs. EP 2.0 30 September 2018
PHR1587-1G Thimerosal LRAA4572 Requal vs. USP R068V0 30 September 2018
PHR1847-500MG Ceftazidime LRAB0132 Requal vs. USP R08540 30 September 2018
PHR1152-1G Phenyl Salicylate Melting Point Standard LRAA7176 Correcting lot number in page 2 8 October 2018
PHR1632-500ML Pioglitazone HCl LRAB3624 Update CRM Expirtion to 12/31/2021 16 October 2018
PHR1081-10G Octinoxate LRAB3324 Correct expiration date  23 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
PHR1100-1G L-Phenylalanine P500100/LRAA7164/LRAB9001 Requal vs. EP 5.0 31 October 2018
PHR1518-1G Polydimethylsiloxane LRAA3325 Requal vs. USP R067P0 31 October 2018
PHR1536-200MG Norphenylephrine Hydrochloride LRAA3654/LRAB9974 Requal vs. USP R069W0 31 October 2018
PHR1063-3X1.2ML Residual Solvents - Class I Mix LRAA0990/LRAA8973/LRAB3312 Requal vs. USP R053P0 31 October 2018
PHR1579-500MG Ursodiol LRAA4495/LRAB5519 Requal vs. USP R058U0 31 October 2018
PHR2004-50MG Chlorpheniramine Impurity A LRAB4751 Requal vs. EP 5.0 31 October 2018
PHR1528-200MG Oxaliplatin LRAA3646/LRAB3831 Requal vs. EP 5.0 31 October 2018
PHR1669-100MG 2,6-Dimethylaniline (Lidocaine RCA) LRAA6005/LRAB1757/LRAB7758 Requal vs. EP 2.0 31 October 2018
PHR1551-3X1.2ML Acetonitrile LRAA4467/LRAB0293 Requal vs. USP R046M0 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
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

 

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

 

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

Part Number Description Lot #
PHR1423-1G Sodium Nitroprusside LRAB7818
PHR1470-500MG Scopolamine Hydrobromide LRAB7821
PHR1001-1G Sucrose LRAB7831
PHR1556-3X1.2ML Methyl Isobutyl Ketone LRAB9508
PHR1855-500MG Telmisartan LRAB8977
PHR1053-1G Albuterol Sulfate (salbutamol sulphate) LRAC0581
PHR1068-1G Edetate Disodium (disodium edetate) LRAC0582
PHR1097-1G L-Tyrosine LRAC0585
PHR1125-1G Glutamine LRAC0586
PHR1131-1G Verapamil Hydrochloride LRAC0587
PHR1152-1G Phenyl Salicylate Melting Point Standard LRAC0592
PHR1132-1G Metoclopramide Hydrochloride LRAC0588
PHR1142-1G Progesterone LRAC0591
PHR1141-1G Ondansetron Hydrochloride LRAC0590
PHR1137-1G Isopropyl Palmitate (Isopropyl hexadecanoate) LRAC0589
PHR1676-100MG Cilostazol Related Compound C LRAC0578
PHR1493-500MG Pilocarpine Hydrochloride LRAC0579
PHR1590-1G Bacitracin LRAC0580
PHR1087-1G Sulfapyridine Melting Point Standard LRAC0584
PHR1510-1G Edetate Calcium Disodium LRAC0607
PHR1101-1G L-Lysine Hydrochloride LRAC0634
PHR1396-1G Methotrexate LRAB9958
PHR1051-1.5G Propylene Glycol LRAB9658
PHR1685-1G Fexofenadine Hydrochloride LRAB9160
PHR1627-100MG Vecuronium Bromide LRAC0703
PHR1170-3X1.2ML Residual Solvent Class II - Methanol LRAC0701
PHR1529-1G Menthyl Anthranilate LRAC0702
PHR1564-200MG Carbazole (Carprofen Related Compound A) LRAC0704
PHR1710-40MG Cetirizine Hydrochloride Related Compound A LRAC0705
PHR1605-1G Colistin Sulfate LRAB7806
PHR1600-1G Topiramate LRAB9199
PHR1568-200MG 4-(Trifluoromethyl)aniline (Leflunomide Related Compound A) LRAC0824
PHR1659-1G Flucytosine LRAC0825
PHR1847-500MG Ceftazidime LRAB8979
PHR1487-500MG Kanamycin Sulfate LRAB7808
PHR1089-1G Cimetidine Hydrochloride LRAC0909
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