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
PHR1824-50MG Pramipexole Related Compound D LRAA9409 CAS# Correction 05 July 2018
PHR1905-25MG Citalopram Related Compound G LRAB2757 Update CAS# 16 July 2018
PHR1291-500MG Cefazolin LRAB0131 Requal vs. EP 4.0 20 July 2018
PHR1235-1G Retinyl Palmitate LRAB6688 Added Isomeric Determination 27 July 2018
PHR1330-5G Monobasic Potassium LRAB0833/LRAA9124 Requal vs USP R072S0 31 July 2018
PHR1028-1G 1,4-Benzoquinone P500028/LRAA5632/LRAA2189 Requal vs USP R06860 31 July 2018
PHR1325-500MG Oxytetracycline Hydrochloride LRAA9119/LRAA0828 Correct Nominal Package Size from 1G to 500MG 31 July 2018
PHR1200-1G p-Chloroaniline P500200/LRAA9015 Requal vs. USP R07220 31 July 2018
PHR1803-200MG Paclitaxel LRAA9808 Requal vs. USP R04650 31 July 2018
PHR1739-200MG 2-Aminophenol (Mesalazine Impurity C) LRAA7943 Requal vs. EP 2.0 31 July 2018
PHR1475-1G Disodium Inosinate LRAA3023/LRAB5131 Requal vs. USP G1J162 31 July 2018
PHR1265-1G Carvedilol LRAA9063/P500265 Requal vs. EP 2.0 BP 3786 31 July 2018
PHR1418-1G Succinic Acid LRAA2482/LRAA9200 Requal vs. USP R064Y0 31 July 2018
PHR17323-4x250MG Vancomycin Hydrochloride LRAA7911/LRAB3620 Requal vs. USP R07250 31 July 2018
PHR1091-1G Vanillin Melting Point Standard P500091/LRAA6135/LRAB1953 Requal vs. USP L1M294 31 July 2018
PHR1172-1G L-Valine P500172/LRAA7145 Requal vs. EP 2.0 31 July 2018
PHR1055-1G Famotidine P500055/LRAB9138/LRAA7133 Requal vs. EP 3.0 31 July 2018
PHR1128-1G Bupivacaine Hydrochloride P500128/LRAA6762/LRAB9654 Requal vs. USP R04320; BP 3591 31 July 2018
PHR1273-1G Malic Acid LRAA0009/LRAA9070 Requal vs. USP R00651 31 July 2018
PHR1827-500MG Moxidectin LRAB0035 Requal vs. EP 4.0 31 July 2018
PHR1717-500MG Methylprednisolone LRAA7305 Requal vs. USP R09850 31 July 2018
PHR1232-500MG Calcium-D-Pantothenate LRAA8436/LRAB3618 CoA Update USP Assay Statement 15 August 2018
PHR1383-1G Adenine LRAA1639/LRAA9171 Requal vs. USP R068R0 31 August 2018
PHR1928-1G Rosuvastatin Calcium LRAB1666 Requal vs. EP 3.0 31 August 2018
PHR1322-100MG 4,4-Pentamethylene-2-pyrrolidinone (Gabapentin Related Compound A) LRAA0825/LRAA9116 Requal vs. EP 2.0 31 August 2018
PHR1007-1G Mannitol P500007/LRAA7082/LRAA9828/LRAB7668 Requal vs. EP 6.0 31 August 2018
PHR1193-500MG 3,4-Dimethoxybenzyl Alcohol P500193/LRAA9009 Requal vs. USP R05530 31 August 2018
PHR1320-3X1.2ML Acetonitrile-Residual Solvent-Class II LRAA0679/LRAB2956 Requal vs. USP R046M0 31 August 2018
PHR1628-500MG Dexamethasone Phosphate LRAB5094 Requal vs. USP L2M534 31 August 2018
PHR1839-1G Amiloride Hydrochloride LRAA9810 Requal vs. USP R052W0 31 August 2018
PHR1224-1G Aminocaproic Acid LRAA9036 Correcting original release data from 2020 to 2015 31 August 2018
PHR1488-1G Quercetin LRAB7760 Updating impurity value and chromatogram 31 August 2018
PHR1716-500MG Capreomycin Sulfate LRAA7304 Requal vs. USP R085W0 31 August 2018
PHR1737-500MG Colistimethate Sodium LRAA8043 Requal vs. USP R07870 31 August 2018
PHR1715-1G Sisomicin Sulfate LRAA7303 Requal vs. USP R06280 31 August 2018
PHR1616-500MG Granisetron Hydrochloride LRAA4875 Requal vs. USP R062A0 31 August 2018
PHR1092-500MG Cyclosporine (ciclosporin) LRAA8977 No longer valid, replaced with new lot LRAB3757 31 August 2018

 

The following new products were qualified and will be available soon

Part Number Description Lot #
PHR1645-1G Sodium Iron EDTA LRAA5306
PHR1990-1G Clopidogrel Related Compound A LRAB4101
PHR2071-100MG Diphenhydramine Impurity D LRAB8552
PHR1968-20MG Clarithromycin Impurity Q LRAB2774
PHR1966-10MG Clarithromycin Impurities G and O LRAB2772
PHR1965-50MG Ibuprofen Impurity G LRAB8602
PHR1920-500MG Ciclopirox LRAB0980
PHR1991-40MG Clopidogrel Related Compound B LRAB8557
PHR1992-40MG Clopidogrel Related Compound C LRAB8558
PHR1483-1G Ferrous Sulfate LRAA3031
PHR1455-2G Ascorbyl Palmitate LRAA3003
PHR1001-1G Sucrose LRAB7831
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

 

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

Part Number Description Lot #
PHR1810-500MG Tadalafil LRAB8867
PHR1108-1G L-Histidine LRAB9338
PHR1158-1G Benzocaine LRAB9535
PHR1508-500MG Tylosin Tartrate LRAB9534
PHR1134-1G Thymol LRAB9533
PHR1115-1G Stearyl Alcohol LRAB9531
PHR1665-3X1.2ML Chlorobenzene LRAB9285
PHR1174-500MG Fluoroquinolonic acid LRAB9284
PHR1330-5G Monobasic Potassium LRAB7784
PHR1763-1G Cefepime Hydrochloride LRAB8503
PHR1656-1G Cetirizine Hydrochloride LRAB9594
PHR1489-1G L-Arabinitol LRAB9593
PHR1171-3X1.2ML Residual Solvent Class II - Methylene Chloride LRAB9592
PHR1509-500MG Epinephrine Bitartrate LRAB9591
PHR1503-1G Cilostazol LRAB9590
PHR1114-1G Stearic Acid LRAB9601
PHR1678-1G Bicalutamide LRAB9616
PHR1460-500MG Choline Bitartrate LRAB7826
PHR1013-1G Salicylic acid LRAB7852
PHR1107-1G Glutamic Acid LRAB9655
PHR1128-1G Bupivacaine Hydrochloride LRAB9654
PHR1052-1G Metronidazole LRAB9725
PHR1145-1G Doxycycline Hyclate LRAB9726
PHR1028-1G 1,4-Benzoquinone LRAB7811
PHR1165-1G Naproxen Sodium LRAB9727
PHR1655-1G Carbidopa LRAB9749
PHR1722-400MG Triamterene LRAB9729
PHR1110-1G L-Alanine LRAB9728
PHR1056-1G Trimethoprim LRAB9829
PHR7794-1G Gabapentin LRAB7794
PHR1049-1G Glimepiride LRAB7813
PHR1804-500MG Paroxetine Hydrochloride LRAB7850
PHR1557-3X1.2ML Methylene Chloride LRAB7796
PHR1026-500MG Ranitidine Hydrochloride LRAB9973
PHR1536-200MG Norphenylephrine Hydrochloride LRAA3654
PHR1455-2G Ascorbyl Palmitate LRAB7810
PHR1105-1G L-Leucine LRAC0013
PHR1479-1G Erythritol LRAC0014
PHR1772-500MG Meropenem LRAB7853
PHR1812-500MG Tranexamic Acid LRAB8978
PHR1023-1G Theophylline LRAC0044
PHR1043-500MG Prednisolone LRAC0045
PHR1079-1G Tobramycin LRAC0046
PHR1086-1G Acetanilide Melting Point Standard LRAC0047
PHR1598-500MG Pramipexole Dihydrochloride LRAC0049
PHR1683-1G Celecoxib LRAC0050
PHR1700-1G Ribavirin LRAC0051
PHR1588-200MG Piroxicam LRAB8974
PHR1203-3X1ML Benzaldehyde LRAB7805
PHR1312-1G o-Xylene LRAB8972
PHR1524-200MG Tamsulosin Hydrochloride LRAC0156
PHR1167-1G Ciprofloxacin LRAC0157
PHR1474-500MG p-Toluenesulfonamide LRAC0158
PHR1041-500MG Tetracycline Hydrochloride LRAC0159
PHR1124-1G Myristic Acid LRAC0160
PHR1201-500MG Resorcinol LRAC0161
PHR1610-250MG Erythromycin Ethylsuccinate LRAC0162
PHR1625-500MG Rufinamide LRAC0163
PHR1129-1G Tetracaine Hydrochloride LRAC0190
PHR1314-1G p-Xylene LRAB8973
PHR1120-1G Palmitic Acid LRAC0216
PHR1019-1G Benzyl Alcohol LRAC0215
PHR1126-1G Sulfamethoxazole LRAC0232
PHR1092-500MG Cyclosporine (ciclosporin) LRAB3757
PHR1480-200MG Ethinyl Estradiol LRAB9196
PHR1717-500MG Methylprednisolone LRAB8710
PHR1102-1G L-Cysteine Hydrochloride LRAC0359
PHR1647-200MG Chlorpheniramine Related Compound B LRAC0360
PHR1595-500MG Polymyxin B Sulfate LRAC0365
PHR1886-1G Memantine Hydrochloride LRAB9158
PHR1828-500MG Eucalyptol (cineole) LRAB9507
PHR1807-500MG Sildenafil Citrate LRAB9121
PHR1734-1G Ritonavir LRAB9120
PHR1020-5G Glycerin LRAB7812
PHR1693-50MG Pyridoxine Impurity A LRAB7815