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

Product No.	Description	Lot #'s	Type of Change	Date Issued
PHR1562	Trichloroethylene	LRAD3850 / LRAD2587 / LRAC9795 / LRAC8805 / LRAD1320	Requalification Test	4-Nov
PHR1328	Magnesium Carbonate	LRAD3253	Requalification Test	4-Nov
PHR3229	Proparacaine Hydrochloride	LRAC7235 / LRAD9319	Requalification Test	5-Nov
PHR3776	Goserelin Acetate	LRAD3078	Requalification Test	5-Nov
PHR1738	6-(butylamino)-N-(2,6-dimethylphenyl)hexanamide (Bupivacaine Impurity E)	LRAD7806	Requalification Test	5-Nov
PHR2041	N-Methyl-3-phenylpropylamine Solution	LRAD5935	Requalification Test	5-Nov
PHR3233	Quinidine Sulfate	LRAD8568 / LRAC7690	Requalification Test	7-Nov
PHR3120	Pyridostigmine Bromide	LRAD8538	Correct reporting basis- Dried Basis	14-Nov
PHR2728	Docusate Sodium	LRAD8490 / LRAC5930	Requalification Test	14-Nov
PHR1254	Acyclovir	LRAD6999	Rename impurities on page 3 and 4	14-Nov
PHR1236	Retinyl Acetate	LRAD8786	Correct Expiration Date	18-Nov
PHR1563	2-Butanol	LRAD7351	CoA Correction: Storage Temperature	19-Nov
PHR1371	Benzalkonium Chloride 10% Solution	LRAD7901	CoA Content Update: Add Titration Result	19-Nov
PHR3790	Polysorbate 80	LRAD6293 / LRAD2190	Requalification Test	20-Nov
PHR1040	Naproxen	LRAD4816 / LRAD2216	Requalification  to BP lot 4618	20-Nov
PHR1681	Benzalkonium Chloride 50% Solution	LRAD5332	CoA Content Update: Identification Test	20-Nov
PHR1148	4-Aminophenol (Acetaminiphen-Related Compound K) (Paracetamol Impurity K)	LRAD8507	Update Description of CRM	20-Nov
PHR1051	Propylene Glycol	LRAD8166 / LRAD4829	CoA Correction: Method Information (In-House Method)	22-Nov
PHR1959	Salbutamol Impurity B	LRAD5007 / LRAD1321	Requalification Test	22-Nov
PHR1046	Ethylene Glycol	LRAD1871 / LRAD3727 / LRAD6763	Requalification to USP 1265515 lot R211M0	22-Nov
PHR1052	Metronidazole	LRAD4511	Requalification  to BP lot 4707	25-Nov
PHR3868	Benzalkonium chloride (C12)	LRAD5187	CoA Content Update: Typo in analyte name on page 1	25-Nov
PHR1470	Scopolamine HBr	LRAD6798 / LRAD7772	Update CoA details regarding drying conditions	25-Nov
PHR3428	Travoprost Related Compound A	LRAC8157	Update description and analyte information- Solution in Water and Acetonitrile	25-Nov
PHR1234	Cyanocobalamin	LRAD6637	Updated part number	25-Nov
PHR3663	Etodolac Related Compound A	LRAD5256	Expiry Date Correction	26-Nov
PHR1152	Phenyl Salicylate Melting Point Standard	LRAD8514	Header Spelling Update	26-Nov
PHR1236	Retinyl Acetate	LRAD8786 / LRAD4259	Requalification Test	4-Dec
PHR2798	Sotalol HCl	LRAC8265 / LRAD8278	Requalification Test	4-Dec
PHR1339	3-AMINO-1-PROPANOL	LRAD3254	Requalification Test	4-Dec
PHR3254	Triamcinolone Hexacetonide	LRAC7492	Requalification Test	4-Dec
PHR1244	Lindane	LRAD6120	Requalification Test	4-Dec
PHR1315	Valsartan	LRAD6801	CoA Update: Anhydrous content to 99.4 % due to typo in version 1	4-Dec
PHR1590	Bacitracin	LRAC9792	Requalification Test	4-Dec
PHR2547	Oxybutynin Chloride	LRAD2785 / LRAD4807	CoA Update: Correct analyte from Oxybutynin RCA to Oxybutynin Chloride	4-Dec
PHR1608	Lactulose	LRAD8719	Update Instructions for handling and correct use	5-Dec
PHR2676	Ranolazine	LRAD7984	Corrected lot number from LRAD7894 to LRAD7984	5-Dec
PHR1470	Scopolamine HBr	LRAD6798	Expiration date updated	10-Dec
PHR1493	Pilocarpine Hydrochloride	LRAD8132	Update Instructions for handling and correct use	11-Dec
PHR3448	23-EPI-26-Deoxyactein	LRAC8194	Requalification Test	11-Dec
PHR1186	Econazole Nitrate	LRAC7821	Requalification Test	11-Dec
PHR2240	Mevastatin / Lovastatin Impurity A	LRAD5081	Requalification Test	11-Dec
PHR1061	Valproic Acid	LRAD0948	Requalification Test	11-Dec
PHR2879	Levocarnitine Related Compound A	LRAD7078	Requalification Test	11-Dec
PHR2114	Articaine Related Compound A	LRAD6600	Requalification Test	11-Dec
PHR2118	Dimethyl fumarate	LRAD4070 / LRAD1313	Requalification Test	11-Dec
PHR1336	Nimesulide	LRAD5309 / LRAD1252	Requalification Test	11-Dec
PHR1533	Cholesterol	LRAD2787 / LRAD6324	Requalification to USP lot R19500	12-Dec
PHR1020	Glycerin	LRAD8984	Add EP FTIR Traceability	16-Dec
PHR3815-250MG	Eplerenone	LRAD2421	Requalification Test	17-Dec
PHR3852-50MG	Sertraline Hydrochloride (Racemic Mixture)	LRAD2899	Requalification Test	17-Dec
PHR3109	Primidone	LRAC7599 / LRAD8284	Stability Check, Recertification against USP	18-Dec
PHR2152	2-(((R)-2-hydroxy-2-(3-hydroxyphenyl)ethyl) (methyl)amino)succinic acid	LRAE0233 / LRAB9882	Update Certification - by qNMR	19-Dec
PHR1001	Sucrose	LRAD4837 / LRAD6397	Requalification Test	19-Dec
PHR2819	Dantrolene Sodium	LRAD7316	Correct structure and add certified values as the sodium salt	19-Dec
PHR3797-1G	Polysorbate 60	LRAD2191	USP Requalification Test	19-Dec
PHR1016	Chlorpheniramine maleate salt	LRAD9224 / LRAD9224	Update Mass Spectrum	19-Dec
PHR1162	Loperamide Hydrochloride	LRAD4847	Requalification Test	19-Dec
PHR1232	Calcium-d-pantothenate	LRAD8542	Revised use instructions	20-Dec
PHR1920-500MG	Ciclopirox	LRAD6527 / LRAD4817 / LRAD2247 / LRAD1947	USP Requalification Test	2-Jan
PHR1585	Esomeprazole magnesium	LRAD2239 / LRAD6799	Requalification to USP lot R19580	2-Jan
PHR1378	Leflunomide	LRAD6765	Requalification to current BP	2-Jan
PHR3056	Nabumetone	LRAC7223 / LRAD9316	Stability Check, Recertification against USP	3-Jan
PHR3591	Sodium Bicarbonate	LRAD5141	USP Requalification Test	3-Jan
PHR3626	Clonidine Related Compound A	LRAD9397	Expiration Date Correction	3-Jan
PHR2968	Sesame Oil Related Compound B	LRAD9349 / LRAC7719	USP Requalification Test	6-Jan
PHR2806	Mupirocin	LRAD8168	Correct QNMR Internal Standard Information	7-Jan
PHR1717	Methylprednisolone	LRAD8449	Correct QNMR Internal Standard Information	7-Jan
PHR1043	Prednisolone	LRAD9226	Correct QNMR Internal Standard Information	7-Jan
PHR1695	Phenylephrine Related Compound C	LRAD9072	Correct QNMR Internal Standard Information	7-Jan
PHR3037	Methimazole	LRAD8766	Correct QNMR Internal Standard Information	7-Jan
PHR1148	4-Aminophenol	LRAD8507	Correct Expiration Date	7-Jan
PHR1309	Dimethyl Sulfoxide	LRAD8098	Update Refractive Index Specification	8-Jan
PHR1140	Ketorolac Trometamol	LRAD1038	USP Requalification Test	9-Jan
PHR2077	Risedronate Related Compound C	LRAD3884	USP Requalification Test	9-Jan
PHR1312-1G	O-XYLENE	LRAD5622	USP Requalification Test	9-Jan
PHR1313-1G	m-Xylene	LRAD1666	USP Requalification Test	9-Jan
PHR1314-1G	p-Xylene	LRAD5777	USP Requalification Test	9-Jan
RTC000101-20ML	m-Xylene	LRAD0974	USP Requalification Test	9-Jan
RTC000102-20ML	o-Xylene	LRAD1656	USP Requalification Test	9-Jan
PHR2582	Gemcitabine Hydrochloride	LRAD4519	USP Requalification Test	9-Jan
PHR1832	Fenbendazole	LRAD4057	Update CoA Content	9-Jan
PHR3524	Indole	LRAD8178	Requalification to USP F11530	9-Jan
PHR3065	Nimodipine Related Compound A	LRAC7700	Requalification Test	14-Jan
PHR3601	Trandolapril Related Compound D	LRAD0231	Addition of EP Traceability	14-Jan
PHR1059	Omeprazole	LRAD4402	Requalification to BP lot 4311 and USP lot R19580	15-Jan
PHR1305	Sodium Dodecylbenzenesulfonate	LRAD6515	Update Certified Value Reporting Basis	17-Jan
PHR1379	Atropine Sulfate	LRAD2317 / LRAD8477	EP Requalification Test	17-Jan
PHR1306	3-Tert-Butyl-4-Hydroxyanisole	LRAD6329	Correct Certification Process Details	17-Jan
PHR1600	Topiramate	LRAD8169	Addition of EP Traceability	17-Jan
PHR1309	Dimethyl Sulfoxide	LRAD8098	Add EP Refractive Index Test	21-Jan
PHR3421	Mupirocin Lithium	LRAC8278	USP Requalification Test	22-Jan
PHR1694	Pyridoxine Impurity B	LRAD8137	Correct Molecular Mass	23-Jan
PHR3272	Balsalazide Related Compound B	LRAC7026	USP Requalification Test	23-Jan
PHR3407	Pravastatin Sodium	LRAC8187	Update BP Labeled Content	27-Jan
RTC000090	Isopropyl acetate	LRAD1657	USP Requalification Test	30-Jan
PHR2109	Isopropyl acetate	LRAD3648	USP Requalification Test	30-Jan
PHR1172	L-Valine	LRAD3725 / LRAD6222	USP Requalification Test	30-Jan
PHR3623-50MG	Levalbuterol Related Compound E	LRAD2961	USP Requalification Test	30-Jan
PHR1330	Monobasic Potassium Phosphate	LRAD4513 / LRAD6300	USP Requalification Test	29-Jan
PHR2890	Polyethylene Glycol 1000	LRAC6784 / LRAD9080	USP Requalification Test	30-Jan
PHR2882-1G	Soybean Oil	LRAD0590 / LRAD9626	USP Requalification Test	30-Jan
PHR1155-1G	Octyldodecanol	LRAD5315	EP Requalification Test	30-Jan
PHR1155	Octyldodecanol	LRAD4596	EP Requalification Test	30-Jan
PHR2940-300MG	Amifostine	LRAD0467	USP Requalification Test	31-Jan
PHR3181	Hexylene Glycol	LRAC7565 / LRAD8125	USP Requalification Test	3-Feb
PHR1404	Cyclophosphamide	LRAD5029	Template Update	16-Jan
PHR3218	Pentoxifylline	LRAD8127	Requalification to UPS R19380	4-Feb
PHR1200	p-Chloroaniline	LRAD9192	Correct USP Lot Number	5-Feb
PHR2994	Aminolevulinic Acid Related Compound B	LRAE0360	USP Requalification Test	6-Feb
PHR3317	Flavoxate Related Compound A	LRAC7867 / LRAE0365	USP Requalification Test	10-Feb
PHR2726	Carboxymethylcellulose Sodium	LRAD6430	USP Requalification Test	10-Feb
PHR2731	Nonoxynol 9	LRAD5680	USP Requalification Test	10-Feb
PHR1379	Atropine Sulfate	LRAD8477	Add Instructions for Use	11-Feb
PHR1534	Griseofulvin	LRAD6819	USP Requalification Test	6-Feb
PHR1604	Pantoprazole Sodium	LRAD8160	Add Basis to assay and mass balance	13-Feb
PHR3525	rac-β-Tocopherol Solution	LRAD9802 / LRAD8458	Correct Units on the certified value	13-Feb
PHR1900	Fluconazole Impurity A	LRAD5778	Structure Correction	13-Feb
PHR1024	D-Lactose Monohydrate	LRAD9675	Correct reporting basis	13-Feb
PHR1083	Octocrylene	LRAD5337 / LRAD7913	USP Requalification	14-Feb
PHR1884	Latanoprost	LRAD2584 / LRAD5321 / LRAD3691	USP Requalification	14-Feb
PHR1786	Chondroitin Sulfate Sodium	LRAD8705	Add instructions for use	18-Feb

THE FOLLOWING NEW PRODUCTS WERE RECENTLY RELEASED

Product No.	Description	API Family
PHR8667-1EA	Oligonucleotide HPLC Performance Standard Mix,  12-33 NT	-
PHR3443-100MG	S-Adenosyl-L-Homocysteine	-
PHR9274-100MG	2-Mercaptoethanol	-
PHR9269-100MG	Benzenesulfonic acid	-
PHR3650-1G	5'-Cytidylic Acid	-
PHR9193-50MG	4-2-(tert-Butylamino)-1-methoxyethyl-2-(hydroxymethyl)phenol	Albuterol, Salbutamol
PHR9280-30MG	Levamlodipine	Amlodipine
PHR9277-30MG	Aripiprazole Impurity C	Aripiprazole
PHR9301-30MG	Aripiprazole Butanoic Acid Impurity	Aripiprazole
PHR9288-30MG	8-Hydroxy-3,4-dihydroquinolin-2(1H)-one	Aripiprazole
PHR9126-50MG	Aripiprazole Impurity G	Aripiprazole
PHR9279-30MG	Aripiprazole Hydroxyquinolinone Analog	Aripiprazole
PHR9127-100MG	Aripiprazole Impurity D	Aripiprazole
PHR3834-25MG	Open Ring Aztreonam	Aztreonam
PHR2946-40MG	Bendamustine Related Compound D	Bendamustine
PHR9312-30MG	16α,17,21-Trihydroxy-pregna-1,4,9(11)-triene-3,20-dione	Budesonide
PHR9314-30MG	Desonide 21-Acetate	Budesonide
PHR3763-250MG	Bumetanide	Bumetanide
PHR3844-500MG	Cephapirin Sodium	Cephapirin
PHR9320-30MG	tert-Octylamine	Clavulanate Potassium
PHR9310-30MG	Clopidogrel Thieno Impurity	Clopidogrel Bisulfate
PHR9324-30MG	methyl 2-(2-chlorophenyl)-2-((2-(thiophen-2-yl)ethyl)amino)acetate hydrochloride	Clopidogrel Bisulfate
PHR1234-100MG	Cyanocobalamin	Cyanocobalamin
PHR2317-100MG	Desloratadine Impurity A	Desloratadine
PHR9253-50MG	Dexamethasone impurity H (17-hydroxy-16α-methyl-3,20-dioxopregna-1,4,9(11)-trien-21-yl acetate,)	Dexamethasone
PHR3663-50MG	Etodolac Related Compound A	Etodolac
PHR9350-30MG	Glicliazide Impurity B	Gliclazide
PHR9283-30MG	Isopropyl 4-acetylbenzoate	Ibuprofen
PHR3327-100MG	Ioversol Related Compound A	Ioversol
PHR3666-30MG	Ipratropium Bromide Related Compound B	Ipratropium Bromide
PHR3755-250MG	Isocarboxazid	Isocarboxazid
PHR3021-50MG	Latanoprost Related Compound E	Latanoprost
PHR3458-100MG	Levocabastine Hydrochloride	Levocabastine
PHR2572-50MG	Ropivacaine Related Compound A	lidocaine Ropivacaine
PHR9083-100MG	phenylazosalicylic acid	Mesalamine
PHR9351-30MG	N-nitroso Methylphenidate	Methylphenidate
PHR8986-250MG	Methylphenidate HCl	Methylphenidate
PHR8952-500MG	Mirtazapine	mirtazapine
PHR3893-30MG	Mometasone Furoate Impurity F	Mometasone Furoate
PHR8861-1G	Morphine Sulfate	Morphine Sulfate
PHR8613-50MG	Nicotine Related Compound E	Nicotine
PHR3779-30MG	Nifedipine Impurity B	Nifedipine
PHR3065-100MG	Nimodipine Related Compound A	Nimodipine
PHR3699-40MG	Verbascoside	Olive Leaf
PHR2546-50MG	Oxaliplatin Related Compound F	Oxaliplatin
PHR3671-50MG	Oxytetracycline Impurity F	Oxytetracycline
PHR2272-100MG	4-Dehydroxy-4-chloro Penciclovir	Penciclovir
PHR9319-30MG	17α-Hydroxy13(17)a-homoprednisolone	prednisolone
PHR9117-50MG	Prednisone Impurity K	Prednisolone/Prednisone
PHR3118-50MG	Propofol Related Compound C	Propofol
PHR3726-50MG	Rotigotine Related Compound C	Rotigotine
PHR3680-200MG	Solifenacin Succinate	solifenacin
PHR3689-40MG	Telmisartan Related Compound B	Telmisartan
PHR9260-100MG	Venlafaxine Impurity C as Hydrochloride	Venlafaxine
PHR8876-50MG	Verapamil Impurity H	Verapamil
PHR8657-50MG	Zonisamide Related Compound C	Zonisamide

THE FOLLOWING NEW BATCHES OF EXISTING PRODUCTS WERE QUALIFIED AND WILL BE AVAILABLE SOON

Product No.	Description	Lot #
PHR1016	Chlorpheniramine Maleate	LRAD9224
PHR2801	Ethylhexyl Triazone	LRAD8782
PHR1840	Aminobenzoic Acid	LRAD9231
PHR2199	Apigenin-7-Glucoside	LRAD8709
PHR2493	Ketorolac Related Compound A	LRAD7790
PHR1912	Benazepril Hydrochloride	LRAD9160
PHR1510	Edetate Calcium Disodium	LRAD9191
PHR2361	Verapamil Related Compound B	LRAD7420
PHR1379	Atropine Sulfate	LRAD8477
PHR2241	Melatonin Related Compound A	LRAD8481
PHR1145	Doxycycline Hyclate	LRAD8730
PHR2785	Metamizole Impurity C	LRAD9670
PHR1798	Levamisole HCl Intermediate	LRAD9169
PHR1163	Miconazole Nitrate	LRAD8718
PHR2804	Trimebutine maleate	LRAD9204
PHR1164	Amiodarone Hydrochloride	LRAD9159
PHR1102	L-Cysteine Hydrochloride	LRAD9220
PHR1307	Captopril	LRAD8727
PHR1687	Cyclohexane	LRAD9207
PHR2561	Alpha Lipoic Acid	LRAD9222
PHR2722	Isoproterenol Hydrochloride	LRAD8754
PHR1074	Oxybenzone	LRAD9678
PHR1002	Fructose	LRAD9529
PHR1827	Moxidectin	LRAD9581
PHR3790	Polysorbate 80	LRAD9673
PHR1037	Thiamine HCl	LRAD9213
PHR1058	Clotrimazole	LRAD9200
PHR2086	Maltotriose	LRAD9578
PHR1669	2,6-Dimethylaniline	LRAD8728
PHR1834	Itraconazole	LRAD9240
PHR2799	Diosmin	LRAD9193
PHR1236	Retinyl Acetate	LRAD8786
PHR1640	Citalopram HBr	LRAD8770
PHR1656	Cetirizine HCl	LRAD9238
PHR1950	Spiramycin	LRAD7612
PHR1554	Heptane	LRAD8779
PHR1027	Guaifenesin	LRAD9235
PHR1581	Uracil	LRAD9239
PHR1046	Ethylene Glycol	LRAD8503
PHR1013	Salicylic Acid	LRAD8769
PHR2099	Cefotaxime Sodium	LRAD8772
PHR1434	Sodium Metabisulfite	LRAD9183
PHR1000	Dextrose	LRAD8776
PHR1557	Methylene Chloride	LRAD9232
PHR1685	Fexofenadine HCl	LRAD8513
PHR1237	Cholecalciferol	LRAD9206
PHR1281	Albendazole	LRAD8762
PHR1454	Arginine HCl	LRAD9237
PHR1443	Irbesartan	LRAD8755
PHR2962	Praziquantel Related Compound B	LRAD8083
PHR1020	Glycerin	LRAD8984
PHR3404	Chlorthalidone	LRAD9196
PHR3820	Norepinephrine Bitartrate	LRAD9521
PHR1241	L-Methionine	LRAD9538
PHR1909	Atenolol	LRAD8758
PHR1682	Baclofen	LRAD8774
PHR2202	Chlorogenic Acid	LRAD9530
PHR1333	Epigallocatechin gallate	LRAD8791
PHR3789	Polysorbate 20	LRAD9676
PHR1711	Amantadine HCl	LRAD8505
PHR2449	Memantine Related Compound A	LRAD9170
PHR1162	Loperamide HCl	LRAD9172
PHR1081	Octisalate	LRAD8534 / LRAD8544
PHR1298	Terbinafine Hydrochloride	LRAD9542
PHR1243	Guanine	LRAD8080
PHR1335	Labetalol HCl	LRAD9523
PHR3195	Levocetirizine Dihydrochloride	LRAD9943
PHR1519	Sulfacetamide Sodium	LRAD9189
PHR1432	N-Acetyl Glucosamine	LRAD9546
PHR1553	Dimethylformamide	LRAD9694
PHR1072	2-Propanol	LRAD9954
RTC000096	Toluene	LRAD8483
PHR2872	Hydroxyzine Related Compound A	LRAD8131
PHR2455	Naphazoline Related Compound A	LRAD9682
PHR1273	Malic Acid	LRAD9697
PHR1294	Chlorhexidine digluconate	LRAD8759
PHR2583	Memantine Related Compound D	LRAD9209
PHR1590	Bacitracin	LRAD8535
PHR1491	Neomycin Sulfate	LRAD7985
PHR2718	Irinotecan Related Compound B	LRAD9161
PHR1024	Lactose Monohydrate	LRAD9675
PHR1569	Levocarnitine	LRAD9572
PHR1043	Prednisolone	LRAD9226
PHR2527	Naproxen Related Compound A	LRAD9922
PHR1396	Methotrexate	LRAD9225
PHR1021	Clindamycin Phosphate	LRAD8763
PHR1921	Clobetasol Propionate	LRAD9674
PHR1740	1-Vinyl-2-pyrrolidone	LRAD9580
PHR1930	Ethambutol HCl	LRAD8726
PHR1271	Levodopa	LRAD8508
PHR1052	Metronidazole	LRAD9203
PHR2326	Guaifenesin Impurity D	LRAD9402
PHR1445	Orlistat	LRAD9536
PHR1040	Naproxen	LRAD9197
PHR2558	1,4-Sorbitan	LRAD9165
PHR1810	Tadalafil	LRAD9534
PHR1204	Benzophenone	LRAD8820
PHR1851	Olmesartan Medoxomil	LRAD8760
PHR1200	p-Chloroaniline	LRAD9192