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
PHR1817-100MG Furosemide Related Compound A LRAB3836 CoA Correction-Update Name 02 August 2017
PHR1150-1G 4-Nitrophenol LRAA8987/P500150 CoA Correction-Update Name 02 August 2017
PHR1322-100MG Gabapentin Related Compound A LRAA9116/LRAA0825 CoA Correction-Update Name 02 August 2017
PHR1400-1G Monetasone Furoate LRAA9186 CoA Correction-Update Expiration Date 03 August 2017
PHR1809-150MG Tacrolimus LRAA8723 Requal vs. USP R055E0 04 August 2017
PHR1465-500MG Pantolactone LRAA3013 Requal vs. USP 04990 31 August 2017
PHR1226-1G Cetylpyridinium Cl P500226/LRAA9038 Requal vs. USP J2K032 31 August 2017
PHR1308-1G Propranolol Hydrochloride LRAA0068/LRAA9104 Requal vs. USP R031H0; BP 3911 31 August 2017
PHR1535-500MG Estrone LRAA3653/LRAA9238 Requal vs. USP R030H0 31 August 2017
PHR1118-1G Propyl Gallate P500118 Requal vs. USP R043H0 31 August 2017
PHR1156-1G Acetyltributyl Citrate LRAA8991/P500156 Requal vs. USP R053A0 31 August 2017
PHR1125-1G L-Glutamine P500125/LRAA7149 Requal vs. USP R049A0 31 August 2017
PHR1542-1G Moxifloxacin Hydrochloride LRAA7396 Requal vs. USP R03640 31 August 2017
PHR1142-1G Progesterone P500142/LRAA7142 Requal vs. EP 4.0 31 August 2017
PHR1502-500MG Berberine Chloride LRAA3050/LRAA9232 Requal vs. USP R04130; BP 3504 31 August 2017
PHR1252-500MG Procainamide Hydrochloride P500252/LRAA9056 Requal vs. USP I1I286 31 August 2017
PHR1088-1G Azithromycin P500088/LRAA8976 Requal vs. USP R043P0 31 August 2017
PHR1421-1G Chlorhexidine LRAA2485/LRAA9203 Requal vs. EP 5.0 31 August 2017
PHR1063-3x1.2ML Residual Solvents Mixture Class I LRAA8973/LRAA099 Requal vs. EP 7.0 31 August 2017
PHR1063-3x1.2ML Residual Solvents Mixture Class I LRAB3312 Requal vs. EP 7.0 31 August 2017
PHR1152-1G Phenyl Salicylate Melting Point Standard P500152/LRAA7176 Requal vs. USP F2M306 31 August 2017
PHR1028-1G 1,4-Benzoquinone LRAA2189/LRAA5632 CoA Correction- TOC General Chapter 31 August 2017
PHR1001-1G Sucrose LRAA6758/LRAA8930 CoA Correction- TOC General Chapter 31 August 2017
PHR1592-1G Tenofovir LRAA4708 CoA Correction- CAS and MW 31 August 2017
PHR1781-500MG Levothyroxine LRAA8502 Requal vs. EP 2.0; BP: 3236 29 September 2017
PHR1363-2.5G Hydrocortisone LRAA1467 Requal vs. USP R052H0 29 September 2017
PHR1392 Risperidone LRAA1899/LRAA9178 Requal vs. USP R047D0; BP 3537 29 September 2017
PHR1445-1G Lidocaine Related Compound H LRAA2822/LRAA9219 Requal vs. USP R03230 29 September 2017
PHR1006-1G Linezolid LRAB1911/LRAB6505/P500006 Requal vs. USP R055R0 29 September 2017
PHR1513-500MG Hydrocortisone Acetate LRAA3320/LRAB3055 Requal vs. USP R04690 29 September 2017
PHR1015-1G Metformin Related Compound C LRAA7135/P500015 Requal vs. USP R04070; BP3764 29 September 2017
PHR1613-1G Citalopram Related Compound D LRAA4872 CoA Correction - updating instruction for use 19 September 2017
PHR1014-500MG Pyridoxine Hydrochloride LRAB3713 CoA Correction - Update Expiration 20 September 2017
PHR1631-500MG Acetaminophen LRAB5521 CoA Correction - Update Expiration 20 September 2017
PHR1673-100MG Citalopram Related Compound C LRAB3729 CoA Correction - Update Expiration 20 September 2017
PHR1885-500MG Citalopram Related Compound H LRAB0639 CoA Correction - Update Expiration 20 September 2017
PHR1606-1G Citalopram Related Compound E LRAB3722 CoA Correction - Update Expiration 20 September 2017
PHR1506-50MG Diphenhydramine Related Compound B LRAB5018 CoA Correction - Update Expiration 20 September 2017
PHR1903-30MG Diphenhydramine LRAB0345 CoA Correction - Update Expiration 20 September 2017
PHR1036-500MG Amoxapine LRAB3720 CoA Correction - Update Expiration 20 September 2017
PHR1005-1G Phenyl Salicylate Melting Point Standard LRAB3711 CoA Correction - Update Expiration 20 September 2017
PHR1902-50MG Oseltamivir Phosphate LRAB1228 CoA Correction - Update Expiration 20 September 2017
PHR1906-50MG Magensium Stearate LRAB2758 CoA Correction - Update Expiration 20 September 2017
PHR1904-50MG Lamotrigine LRAB1229 CoA Correction - Update Expiration 20 September 2017
PHR1899-50MG Orlistat LRAB0343 CoA Correction - Update Expiration 20 September 2017
PHR1861-50MG Sorbitol LRAB0137 CoA Correction - Update Expiration 20 September 2017
PHR1841-500MG Enrofloxacin LRAB2753 CoA Correction - Update Expiration 20 September 2017
PHR1304-1G Butylated Hydroxyanisole LRAA9100/LRAA0064 Requal vs. USP R043W0 29 September 2017
PHR1152-1G Phenyl Salicylate Melting Point Standard LRAA7176 CoA Correction- Lot # 21 September 2017
PHR1234-1G Cyanocobalamin LRAB2381/LRAA7907 Requal vs USP F07440; EP: 5.0; BP: 3935 29 September 2017
PHR1610-250MG Erythromycin Ethylsuccinate LRAA4726 Requal vs. USP R064T0 29 September 2017

 

The following new products were qualified and will be available soon

Part Number Description Lot #
PHR1846-30MG Fluticasone Related Compound J LRAB0747
PHR1864-500MG Brompheniramine Maleate LRAB0504
PHR2011-100MG Gabapentin Related Compound B LRAB4759
PHR1902-50MG Citalopram Related Compound C LRAB1228
PHR1906-50MG Citalopram Related Compound H LRAB2758
PHR1841-500MG Amoxapine LRAB2753
PHR1904-50MG Citalopram Related Compound E LRAB1229
PHR1863-200MG Citalopram Related Compound F LRAB0139
PHR1903-30MG Citalopram Related Compound D LRAB0345
PHR1893-1G Zoledronic Acid LRAB0346
PHR1867-1G Rivastigmine Tartrate LRAB1259
PHR1921-500MG Clobetasol Propionate LRAB1226
PHR1950-500MG Spiramycin LRAB1418
PHR1899-50MG Diphenhydramine Related Compound B LRAB0343
PHR1861-50MG Dephenhydramine Impurity C LRAB0137
PHR1897-50MG Diphenhydramine Impurity B LRAB0341
PHR1885-500MG Linezolid LRAB0639
PHR1977-50MG Lidocaine Impurity D LRAB2779
PHR1866-1G Ezetimibe LRAB0503
PHR1808-100MG Sodium Aminosalicylate Dihydrate LRAA8625
PHR1881-500MG Articaine Hydrochloride LRAB0608
PHR1668-1G Retinyl Propionate LRAB5021
PHR1628-500MG Dexamethasone Phosphate LRAB5094
PHR1891-500MG Tolerodine Tartrate LRAB0501
PHR2014-100MG Triamterene Related Compound A LRAB5615
PHR1947-500MG Salmeterol Xinafoate LRAB5617
PHR1970-100MG Acetaminophen Impurity C LRAB2775
PHR1971-100MG Acetaminophen Impurity E LRAB2776
PHR1972-100MG Acetaminophen Impurity G LRAB5677
PHR1973-100MG Acetaminophen Impurity I LRAB2777
PHR1890-50MG Tiotropium Bromide Monohydrate LRAB0347
PHR1889-500MG Rizatriptan Benzoate LRAB0554

 

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

Part Number Description Lot #
PHR1542-1G Moxifloxacin Hydrochloride LRAB3724
PHR1005-1G Acetaminophen LRAB3711
PHR1036-500MG Pyridoxine Hydrochloride LRAB3720
PHR1506-50MG Metformin Related Compound C LRAB5018
PHR1014-500MG Hydrocortisone LRAB3713
PHR1834-200MG Itraconazole LRAB3721
PHR1606-1G Hydrocortisone Acetate LRAB3722
PHR1472-1G Tartaric Acid LRAB3726
PHR1673-100MG Lidocaine Related Compound H LRAB3729
PHR1631-500MG Risperidone LRAB5521
PHR1304-1G Butylated Hydroxyanisole LRAB3751
PHR1258-1G Chloroquine Phosphate LRAB3715
PHR1310-1G Benzene LRAB5022
PHR1085-10G Homosalate LRAB5025
PHR1555-3X1.2ML Hexane LRAB5023
PHR1031-500MG alpha-Tocopherol LRAB3718
PHR1127-1G Amoxicillin Trihydrate LRAB3723
PHR1222-500MG Chlorhexidine Acetate LRAB3716