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 COA’s 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
PHR1558-3x1.2ML Pyridine LRAA4474 / LRAA0292 CoA Correction-USP Lot 08 January 2018
PHR1499-500MG Flurbiprofen LRAA3047 / LRAA9230 CoA Correction-USP Lot and Labeled Content 08 January 2018
PHR1557-3x1.2ML Methylene Chloride LRAA8514 CoA Correction-USP Lot 09 January 2018
PHR1921-500MG Clobetasol Propionate LRAB1226 CoA Correction- Expiration Date 09 January 2018
PHR1008-10G Ascorbic Acid LRAB3631 CoA Correction- Expiration Date 31 January 2018
PHR1718-500MG Methylprednisolone Acetate LRAA7306 CoA Correction-Product's Name 31 January 2018
PHR1573-500MG Phenformin Hydrochloride LRAA4489 CoA Correction-Remove USP's Assay and FTIR Data 31 January 2018
PHR1875-30MG Valsartan Related Compound A LRAB1041 CoA Correction- HPLC Method 31 January 2018
PHR1233-1G Biotin P500233 / LRAA9042 / LRAB6597 Requal vs. USP R04670 31 January 2018
PHR1638-1G Alfuzosin Hydrochloride LRAA5304 Requal vs. USP F1H162; BP 2994 31 January 2018
PHR1045-1G Diethylene Glycol LRAB0287 / P500045 / LRAA5982 Requal vs. USP R05070 31 January 2018
PHR1805-1G Piperacillin LRAB8816 Requal vs. USP R07230; EP 5.0 31 January 2018
PHR1207-3x1.2ML Methyl Ethyl Ketone P500207 / LRAB3828 Requal vs. USP R063M0 31 January 2018
PHR1144-1G Diclofenac sodium P500144 Requal vs. USP R038G0; BP: 3666 31 January 2018
PHR1768-1G Dexamethasone Sodium Phosphate LRAA8194 Requal vs. USP R06110; EP: 7.0; BP: 3920 31 January 2018
PHR1620-1G Fluvastatin Sodium LRAA5290 Requal vs. USP R061P0; BP: 3715 31 January 2018
PHR1782-1G Hydroxychloroquine LRAA8559 Requal vs. USP R052K0 31 January 2018
PHR1701-1G Triamcinolone Acetonide LRAA6967 Requal vs. USP R05160 31 January 2018
PHR1132-1G Metoclopramide Hydrochloride P500132 / LRAA7152 Requal vs. EP 3.0 BP: 3792 31 January 2018
PHR1386-1G Amylmetacresol LRAA1822 Requal vs. EP 2.0 01 February 2018
PHR1547-3x1.2ML Mesityl Oxide LRAB2715 Requal vs. EP 2.0 and correct Mass Balance value 05 February 2018
PHR1018-500MG Dextromethorphan HBr LRAA9503 Adding mass balance as is basis value 23 February 2018
PHR1494-500MG Pilocarpine Nitrate LRAA3042 Requal vs. USP R06410 28 February 2018
PHR1787-500MG Cytarabine LRAA8717 / LRAB3688 Requal vs. USP R046F0 28 February 2018
PHR1802-300MG Naloxone LRAA8821 Requal vs. USP R05150 28 February 2018
PHR1396-1G Methotrexate LRAA2046 / LRAA9182 Requal vs. EP 8.0 28 February 2018
PHR1361-500MG Calcium Ascorbate LRAA1465 / LRAA9154 Requal vs. USP R053M0 28 February 2018
PHR1059-1G Omeprazole LRAB0280 Requal vs. USP R065N0; EP 5.0; BP 3817 28 February 2018
PHR1735-1G Demeclocycline HCl LRAA7910 Requal vs. USP R024Q1 28 February 2018
PHR1060-1G Mesalamine P500060 / LRAA7173 Requal vs. EP 3.0 28 February 2018
PHR1404-1G Cyclophosphamide LRAB3626 Requal vs. USP R075X0 28 February 2018
PHR1404-1G Cyclophosphamide LRAA2198 Requal vs. USP R075X0 28 February 2018
PHR1376-1G Loratadine LRAA1632 / LRAA9165 Requal vs. USP R052U0 28 February 2018
PHR1165-1G Naproxen Sodium P500165 / LRAA7178 Requal vs. USP R04290 28 February 2018
PHR1312-1G o-Xylene LRAB4770 / LRAB9108 / LRAA0637 Requal vs. USP R040L0 28 February 2018
PHR1313-1G m-Xylene LRAB3625 Requal vs. USP R040L0 28 February 2018
PHR1314-1G p-Xylene LRAA0632 / LRAA9110 Requal vs. USP R040L0 28 February 2018
PHR1051-1.5G Propylene Glycol P500051 / LRAA5984 Requal vs. USP R05310 28 February 2018
PHR1790-1G Eicosapentaenoic Acid Ethyl Ester LRAB2752 Requal vs. EP 5.0 28 February 2018
PHR1115-1G Steryl Alcohol P500115 / LRAA7161 Requal vs. USP R02270; EP 3.0 28 February 2018
PHR1476-1G Diethyl Phthalate LRAA3024 Requal vs. EP 2.0 28 February 2018
PHR1470-500MG Scopolamine HBr LRAA3018 Requal vs. USP L1M054; BP 3835 28 February 2018


The following new products were qualified and will be available soon

Part Number Description Lot #
PHR1953-30MG Fluoxetine Related Compound C LRAB1420
PHR1952-30MG Fluoxetine Related Compound A LRAB1419
PHR2023-50MG Donepezil Related Compound A LRAB7176
PHR1980-20MG Clarithromycin Impurity N LRAB3288
PHR1983-30MG Ibuprofen Impurity O LRAB3996
PHR2020-20MG Candesartan Cilexetil Related Compound F LRAB4750
PHR2002-100MG Folic Acid Impurity D LRAB4757
PHR2021-20MG Candesartan Cilexetil Related Compound G LRAB6842
PHR1939-500MG Hydroxyproline LRAB0981
PHR1945-300MG Ouabain LRAB2762
PHR1963-50MG (+)-Catechin LRAB2766
PHR2018-20MG Candesartan Cilexetil Related Compound B LRAB5321
PHR1928-1G Rosuvastatin Calcium LRAB1666
PHR1924-250MG Dacarbazine LRAB1415
PHR1895-30MG Exemestane RCB LRAB2756
PHR1907-250MG Acebutolol HCl LRAB1221
PHR1930-500MG Ethambutol HCl LRAB0956
PHR1944-1G Quinapril HCl LRAB1234
PHR1922-500MG Cloxacillin Sodium LRAB1227
PHR1927-1G Lopinavir LRAB1665


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

Part Number Description Lot #
PHR1680-1G Desloratadine LRAB6765
PHR1494-500MG Pilocarpine Nitrate LRAB7679 (Alias of LRAA3042)
PHR1565-500MG D4 Cyclomethicone LRAB7695 (Alias of LRAA4481)
PHR1566-500MG D5 Cyclomethicone LRAB7696 (Alias of LRAA4482)
PHR1796-200MG Imipenem LRAB7177
PHR1471-1G Sodium Alginate LRAB5524
PHR1121-10G 2-Phenoxyethanol LRAB7047
PHR1800-100MG Metamizole Sodium LRAB7046
PHR1078-1G Phytonadione LRAB3714
PHR1372-3X1.5ML Methanol LRAB7353