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.

If you wish to be notified of this monthly update by email, please sign up here: COA Updates.

 

COAs for the following products have been updated

Part Number Description Lot #'s Type of Change Date Issued
PHR1749-1G Trimeprazine Tartrate LRAA9455 Update USP Lot Valid Date 3 December 2018
PHR1329-5G Potassium Chloride LRAB7667 CoA Correction: Correct discrepancy in titrtion assay value 19 December 2018
PHR1886-1G Memantine Hydrochloride LRAB9158 CoA Correction: Update Expiration 19 December 2018
PHR1054-1G Riboflavin LRAA7713 CoA Correction: Update FTIR Traceability 20 December 2018
PHR1689-200MG Ammonium Glycyrrhizate LRAA6638/LRAC0910 Requal vs. USP R09190 and EP 5.0 31 December 2018
PHR1072-3X1.2ML 2-Propanol LRAB7677/LRAB3749/P500072/LRAA6500 Requal vs. USP R048P0 31 December 2018
PHR1372-3X1.5ML Methanol LRAA9163 Update Expiration Date 31 December 2018
PHR1372-3X1.5ML Methanol LRAA9411/LRAB7353 Requal vs. USP R07490 31 December 2018
PHR1957-500MG Tenofovir Disoproxil Fumarate LRAB2763 Requal vs. USP R08290 31 December 2018
PHR1141-1G Ondansetron Hydrochloride P500141/LRAA7141/LRAC0590 Requal vs. USP R07740 31 December 2018
PHR1895-30MG Exemestane Related Compound B LRAB2756 Requal vs. USP R08410 31 December 2018
PHR1709-30MG Methyl-D-Sorbosonate (Ascorbic Acid Imp D) LRAA7297 Requal vs. EP 3.0 31 December 2018
PHR1408-1G Sodium Fluoride LRAA2472/LRAA9192 Requal vs. USP R066Y0 31 December 2018
PHR1068-1G Edetate Disodium P500068/LRAA5634/LRAAC0582 Requal vs. EP 2.0 31 December 2018
PHR1618-1G Miconazole LRAA8934/LRAB5528 Requal vs. EP 3.0 10 January 2019
PHR1829-500MG Hypromellose LRAC0715 CoA Correction: Update Massbalance Value 10 January 2019
PHR1674-100MG Lidocaine Related Compound I LRAA6010 CoA Correction: adding LC-MS data 14 January 2019
PHR1257-500MG Lidocaine Hydrochloride LRAB3669 CoA Correction: Update NMR 28 January 2019
PHR1856-1G Quetiapine Fumarate LRAB0282 Requal vs. EP 2.0 31 January 2019
PHR1702-200MG Fluticasone Propionate LRAA6968/LRAB5523 Requal vs. USP R073Y0;BP 4030 31 January 2019
PHR1978-50MG Ibuprofen Impurity J LRAB2591 Requal vs. USP R09260 31 January 2019
PHR1622-3ML Travoprost LRAA5292 Requal vs. USP R078A0 31 January 2019
PHR1619-1G Beclomethasone Dipropionate LRAB3632/LRAA5289 Requal vs. USP R066J0 31 January 2019
PHR1603-1G Montelukast Sodium LRAB3470/LRAB3617 Requal vs. USP R06240 31 January 2019
PHR1188-3X100MG Isotretinoin P500188/LRAA9006 Requal vs. USP R09860 31 January 2019
PHR1078-1G Phytonadione LRAB3714 Requal vs. EP 5.0 31 January 2019
PHR1388-1G Adapalene LRAA9175 Requal vs. EP 2.0 31 January 2019
PHR1323-1G Cystine LRAA9117 Requal vs. USP F2M308 and EP 3.0 31 January 2019
PHR1615-1G Ritodrine Hydrochloride LRAA4874 Requal vs. USP R062H0 31 January 2019
PHR1958-50MG Irbesartan Related Compound A LRAB2764 Requal vs. USP R067E0 31 January 2019
PHR1201-500MG Resorcinol P500201/LRAC0161 Requal vs. EP 2.0 31 January 2019
PHR1829-500MG Hypromellose LRAA9719 Requal vs. USP R08850 31 January 2019
PHR1307-1G Captopril LRAA9103 Requal vs. USP R069U0 31 January 2019
PHR1684-1G Carbimazole LRAA6300 Requal vs. EP 3.0 31 January 2019
PHR1866-1G Ezetimibe LRAB0503 Requal vs. USP R075K0 31 January 2019
PHR1813-50MG Glipizide Related Compound A LRAA8817 Requal vs. USP R077L0 31 January 2019
PHR1679-500MG Atomoxetine Hydrochloride LRAA6124 Requal vs. USP R068E0 31 January 2019
PHR2015-40MG Raloxifene Related Compound C LRAB5322 Requal vs. USP R068X0 31 January 2019
PHR1781-500MG Oseltamivir Phosphate LRAA8502 Requal vs. USP R077H0 31 January 2019
PHR1113-1G Sodium Lactate LRAA6909/LRAB9051 Requal vs. USP R07330 31 January 2019
PHR1020-5G Glycerin LRAB0281 Requal vs. USP R069D0 31 January 2019
PHR1020-5G Glycerin LRAB7812 CoA Correction: Update Assay, LC-MS and NMR spectra 31 January 2019
PHR1093-1G Sulfanilamide Melting Point Standard LRAB1410/LRAA7138 Requal vs. USP R007N1 31 January 2019
PHR1242-500MG Threonine LRAA9046 Requal vs. USP R07940 31 January 2019
PHR1947-500MG Salmeterol Xinafoate LRAB5617 Requal vs. USP R084M0 31 January 2019
PHR1949-2G Sodium Lauryl Sulfate LRAB0984 Requal vs. USP R100F0 31 January 2019
PHR1680-1G Desloratadine LRAB6765/LRAA6125 Requal vs. EP 3.0 31 January 2019
PHR1299-1G Pamabrom LRAA0585/LRAB9095 Requal vs. USP R074H0 31 January 2019
PHR1051-1.5G Propylene Glycol LRAA5984/LRAB0286 Requal vs. USP R081G0, EP 2.0 31 January 2019
PHR1491-1G Neomycin Sulfate LRAA9229/LRAB3300 Requal vs. EP 5.0 31 January 2019
PHR1688-50MG Chlorpheniramine RCC LRAA6385 Requal vs. USP R07600 31 January 2019
PHR1094-1G Phenacetin Melting Point Standard LRAA0835/LRAA8978 Requal vs. USP R066A0 31 January 2019
PHR1129-1G Tetracaine Hydrochloride LRAA7150/LRAC0190 Requal vs. EP 2.0 31 January 2019

 

The following new products were qualified and will be available soon

Part Number Description Lot #
PHR1374-1G Ethylcelluloe LRAA1630
PHR1943-1G Methacholine Chloride LRAB9827
PHR2108-1.2ML 1,2-Dichloroethane LRAB9857
PHR2110-1.2ML N,N-Dimethylacetamide LRAB9779

 

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

Part Number Description Lot #
PHR1533-500MG Cholesterol LRAC0249
PHR1408-1G Sodium Fluoride LRAB7816
PHR1825-1G Olanzapine LRAC0272
PHR1583-1G Megestrol Acetate LRAC1632
PHR1649-30MG Omeprazole RCE LRAC1633
PHR1650-30MG Omeprazole RCI LRAC1635
PHR1664-500MG Rifamycin Sodium LRAC1636
PHR1068-1G Edetate Disodium (disodium edetate) LRAC0266
PHR1037-1G Thiamine HCl LRAB9939
PHR1909-500MG Atenolol LRAC0712
PHR1856-1G Quetiapine Fumarate LRAC0140
PHR1702-200MG Fluticasone Propionate LRAB9941
PHR1978-50MG Ibuprofen Impurity J LRAC0769
PHR1430-1G Dihydroxyacetone LRAC0574
PHR1402-1G Phenoxybenzamine Hydrochloride LRAC1712
PHR1709-30MG Ascorbic Acid Imp D LRAC1733
PHR1103-1G L-Serine LRAC1750
PHR1616-500MG Granisetron Hydrochloride LRAC1751
PHR1188-100MG Isotretinoin LRAC0144
PHR1134-1G Thymol LRAC0147
PHR1076-1G Metoprolol Tartrate LRAC1767
PHR1207-3X1.2ML Methyl Ethyl Ketone LRAC0146
PHR1113-1G Sodium Lactate LRAB7822
PHR1059-1G Omeprazole LRAC0716
PHR1563-1.2ML 2-Butanol LRAC0290
PHR1561-3X1.2ML Tetrahydrofuran LRAC0275
PHR1596-500MG Pemetrexed LRAC1932
PHR1067-1G Carbamazepine LRAC1961
PHR1947-500MG Salmeterol Xinafoate LRAC0767