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
PHR1352-2G	N-Methylpyrrolidone	LRAE0004	Correct Expiration Date	15-Apr
PHR8530-30MG	3-O-Methyl Norbuprenorphine	FC10222403	Updated retest date	15-Apr
PHR3987-30MG	Escitalopram Acid Analog	FN09182424	Updated retest date	15-Apr
PHR3824-500MG	Bisoprolol Fumarate	FN02122501	Updated retest date	15-Apr
PHR8760-50MG	Tacrolimus 8-propyl analog	FN07212401	Updated retest date	15-Apr
PHR8988-25MG	Morphine Related Compound A	FC10092101	Updated retest date	15-Apr
PHR8719-100MG	Ketorolac Tromethamine Impurity G	FN01152401	Updated retest date	15-Apr
PHR8729-20MG	Lamotrigine Related Compound C	FN12052301	Updated retest date	15-Apr
PHR8702-50MG	Diltiazem Related Compound A	FN07252305	Updated retest date	15-Apr
PHR1416-1G	Sodium Citrate	LRAE0139	Corrected Expiration Date	20-Apr
PHR1405-1G	Capecitabine	LRAD7603	USP Requalification Test	20-Apr
PHR1038-500MG	Clarithromycin	LRAD4406	EP Requalification Test	20-Apr
PHR1298-1G	Terbinafine Hydrochloride	LRAD9542	USP Requalification Test	22-Apr
PHR8749-50MG	Orlistat Related Compound A	FN12152304	Updated retest date	28-Apr
PHR8611-50MG	Metaxalone Related Compound B	FN12212301	Updated retest date	28-Apr
PHR8414-1ML	Estriol Related Compound A 1 mg/mL	FN04042404	Updated retest date	28-Apr
PHR8613-50MG	Nicotine Related Compound E	PHR8613-50MG	USP reqaul and Update retest date	28-Apr
PHR-8925-100MG	Human Insulin	FN10142102	Updated retest date	28-Apr
PHR8986-250MG	Methylphenidate HCl	FC01232409	Updated retest date	28-Apr
PHR3838-1G	Methylene Blue	LRAD2701	Update content	30-Apr
PHR1228-500MG	Dexpanthenol	LRAE0134	Added water content and change CoA format	30-Apr
PHR8894-50MG	Lisinopril R,S,S-diketopipera zine	FN04062101	Updated retest date	29-Apr
PHR8823-500MG	Methadone HCl	FC09012103	Updated retest date	29-Apr
PHR1408-1G	Sodium Fluoride	LRAE0133	CoA format update	1-May
PHR1399-1G	Betamethasone Dipropionate	LRAE1399	Update content	4-May
PHR8868-500MG	Butalbital	FC05112201	Updated retest date	6-May
PHR8946-1ML	Tocopherol Peak Identification Solution	FN03222201	Updated retest date	6-May
PHR8667-1EA	Oligonucleotide HPLC Performan	FN05172403	Updated from expiration to retest.	7-May
PHR8778-30MG	Azelastine Related Compound F	FN12152306	Updated retest date	12-May
PHR8622-50MG	Palonosetron Related Compound C	FN02012402	Updated retest date	12-May
PHR8651-100MG	Tryptophan Impurity G	FN05142505	Updated retest date	13-May
PHR8418-30MG	Apixaban Related Compound F	FN04232503	Updated retest date	13-May
PHR1480-200MG	Ethinyl Estradiol	LRAD9726	Correct USP lot number on pg 2	13-May
PHR8419-30MG	Apixaban Related Compound G	FN04232511	Updated retest date	13-May
PHR8569-30MG	2,2'-Oxybis(N-methylethan-1-am	FN04232512	Updated retest date	13-May
PHR8624-30MG	Palonosetron Related Compound	FN04032506	Updated retest date	13-May
PHR8710-30MG	Fosinopril Related Compound G	FN04232508	Updated retest date	13-May
PHR8743-50MG	2,2'-Bisnaloxone	FC05182102	Updated retest date	13-May
PHR1830-100MG	Desogestrel	LRAD9025	EP Requalification Test	15-May
PHR1298-1G	Terbinafine Hydrochloride	LRAD5042	USP Requalification Test	15-May
PHR1320-1.2ML	Residual Solvent - Acetonitrile	LRAD3695	USP Requalification Test	18-May
PHR1162-1G	Loperamide Hydrochloride	LRAD9172	Corrected Expiration Date	14-May
PHR8893-10MG	Progesterone EP Impurity I	FN05172401	Updated retest date	26-May
PHR1563-1.2ML	2-Butanol	LRAD7351 / LRAD9564	USP Requalification Test	26-May
PHR8878-100MG	Fluticasome Related Compound B	FN12212302	USP Requalification Test/Retest Date	27-May
PHR1789-200MG	Doxorubicin Hydrochloride	LRAD8182 / LRAE0180	EP Requalification Test	28-May
PHR1918-50MG	Carbamzepine Related Compound A	LRAD9950	EP Requalification Test	28-May
PHR8605-50MG	Losartan Related Compound C	FN12052203	Updated retest date	1-Jun
PHR8708-100MG	Eszopiclone	FC01232410	Updated retest date	1-Jun
PHR8506-30MG	16alpha-Hydroxy Prednisolone-9(11)-ene Acetate	FN01252405	Updated retest date	1-Jun
PHR8882-30MG	Clindamycin Impurity C	FN02242201	Updated retest date	2-Jun
PHR8955-50MG	Buprenorphine Related Compound A	FC12052204	Updated retest date	2-Jun
PHR1518-1G	Polydimethylsiloxane	FN09192513	Updated CAS #	3-Jun
PHR8876-100MG	Verapamil Impurity H	FN04192302	Updated retest date	3-Jun
PHR8977-200MG	Fentanyl Citrate	FC02082202	Updated retest date	3-Jun
PHR3892-30MG	Mometasone Furoate Impurity E	FN04232505	Updated retest date	4-Jan
PHR8518-30MG	Azithromycin Impurity M	FN04232507	Updated retest date	4-Jan
PHR3747-50MG	Lufenuron Related Compound C	LRAD4539	USP Requalification Test	5-Jun
RTC000080-20ML	Acetonitrile	LRAD3408	USP Requalification Test	8-Jun
PHR3826-1ML	Triethylene Glycol	LRAD8099	USP Requalification Test	8-Jun
PHR8977-200MG	Fentanyl Citrate	FC02082202	Updated retest date	8-Jun
PHR8931-50MG	Lisinopril S,S,S-diketopipe razine	FN04062102	Updated retest date	8-Jun
PHR8708-100MG	Eszopiclone	FC01232410	Updated retest date	8-Jun
PHR1497-1G	Maltose Monohydrate	LRAD9059	Add anhydrous, Update manager signature	9-Jun
PHR8604-50MG	Losartan Related Compound B	FN07252303	Updated retest date	9-Jun
PHR1253-500MG	Acarbose	LRAD9955	Update EP Assay Value	1-Jun
PHR1550-1.2ML	2-ETHOXYETHANOL	LRAD2809	USP Requalification Test	10-Jun
PHR3557-80MG	Dicyclomine Related Compound A	LRAE1337	USP Requalification Test	11-Jun
PHR1363-2.5G	Magnesium Stearate	LRAD5625	Update Assay information	11-Jun
PHR3360-500MG	Cefoperazone Dihydrate	LRAC8247	USP Requalification Test	12-Jun
PHR2972-200MG	Castor Oil	LRAD8964	USP Requalification Test	12-Jun
PHR8978-200MG	Flurazepam HCl	FC12222021	Updated retest date	1-Jul
PHR8601-50MG	Lorazepam Related Compound C	FN05312304	Updated retest date	1-Jul
PHR8843-500MG	Phenobarbital	FC05042103	Updated retest date	1-Jul
PHR8738-500MG	Modafinil	FC088052101	Updated retest date	1-Jul
PHR1655-1G	Carbidopa	LRAD8888	Updated retest date	1-Jul
PHR3099-500MG	Prazosin HCl	FN11262522	lot #, certified & QNMR purity	1-Jul
PHR8960-500MG	Clonazepam	FC08172201	Updated retest date	2-Jul
PHR3064-50MG	Nicotine Related Compound G	LRAE0383	USP Requalification Test	2-Jul
PHR2935-50MG	Adapalene Related Compound E	LRAE1121	USP Requalification Test	2-Jul
PHR1272-500MG	Maleic Acid	LRAD3649 / LRAD7427	EP Requalification Test	2-Jul
PHR8745-500MG	Naltrexone	FN06202101	Updated retest date	2-Jul
PHR8641-100MG	Testosterone acetate	FC04192301	Updated retest date	6-Jul
PHR8703-50MG	Dorzolamide HCl Related Compound A	FN01272307	Updated retest date	6-Jul
PHR8711-50MG	Fosinopril Related Compound H	FN06282202	updated retest date and USP Requal	6-Jul
PHR8999-30MG	Oxycodone Related Compound C	FN05112202	Updated retest date	7-Jul
PHR8973-30MG	Exemestane Related Compound C	FC01272317	Updated retest date	7-Jul
PHR8948-50MG	6-epi-Doxycycline HCl	FN04062103	Updated retest date	7-Jul
PHR8793-50MG	Granisetron Related Compound B	FN01272308	Updated retest date	8-Jul
PHR8831-25MG	Diacetylmorphine Hydrochloride	FC10092103	Updated retest date	8-Jul
PHR8794-50MG	Granisetron Related Compound C	FN05312301	Updated retest date	10-Jul
PHR8400-10MG	Atorvastatin Eliminated Lactone	FN04232509	Updated retest date	13-Jul
PHR8420-30MG	Apixaban Related Compound H	FN05302502	Updated retest date	13-Jul
PHR8573-1ML	N-nitroso-atomoxetine	FN06242503	Updated retest date	13-Jul
PHR8852-250MG	Clorazepate Dipotassium	FC01192409	Updated retest date	13-Jul
PHR8417-30MG	Apixaban Related Compound E	FN04032501	Updated retest date	13-Jul
PHR3930-30MG	Perindopril Related Compound F	FN07022503	Updated retest date	13-Jul
PHR8533-30MG	Gilmepiride Impurity F	FN02262403	Updated retest date	13-Jul
PHR8416-30MG	Apixaban Related Compound D	FN05192503	Updated retest date	13-Jul
PHR8584-100MG	Lorazepam Related Compound A	FN07012502	Updated retest date	13-Jul
PHR8591-1ML	N-Nitroso Ramipril	FN05142503	Updated retest date	13-Jul
PHR8798-50MG	Lacosamide Related Compound F	FN05302306	updated retest date and EP lot	14-Jul
PHR2460-100MG	Glucosamine Impurity E	FN09192505	remove 200 nm assay result	14-Jul
PHR8629-50MG	Pregabalin Related Compound A	FN02072401	Updated retest date	15-Jul
PHR8812-200MG	Tramadol HCl	FC05042101	Updated retest date	15-Jul
PHR8709-50MG	Fosinopril Related Compound A	FN05312302	Updated retest date	16-Jul
PHR8415-250MG	Apixaban	FN04282507	Updated retest date	16-Jul
PHR8713-30MG	Glimepiride Related Compound D	FN09292301	Updated retest date	16-Jul
PHR8723-100MG	Ketorolac Isopropyl Ester	FN07072101	Updated retest date	16-Jul
PHR8762-50MG	Tacrolimus Related Compound A	FN12072301	Updated retest date	16-Jul
PHR8787-50MG	Eszopiclone Related Compound A	FN02012401	Updated retest date	16-Jul
PHR8602-50MG	Lorazepam RCD	FN05302305	Updated retest date	17-Jul
PHR8976-200MG	Fentanyl	FC01272309	Updated retest date	17-Jul
PHR8776-50MG	Azelastane RCB	FN01192408	Updated retest date	17-Jul
PHR8734-50MG	Methotrexate Related Compound E	FN01192402	Updated retest date	17-Jul
PHR2306-100MG	Ropivacaine RCB	LRAD8565	Updated retest date	21-Jul
PHR8989-25MG	Morphine Related Compound B	FC10012113	Updated retest date	21-Jul
PHR8627-50MG	Phenylephrine Related Compound F	FN07252307	Updated retest date	21-Jul
PHR1215-3X1.5ML	Lactic Acid	LRAD9977	Update MS content and signature, removed description	22-Jul
PHR1737-500MG	Colistimethate Sodium	LRAD7945	Update content and signature	17-Jun
PHR1804-500MG	Paroxitine HCl	LRAE0175	Correct spelling error and update signature	16-Jun
PHR1716-500MG	Capreomycin Sulfate	LRAD5981	Update content	14-Jul
PHR1396-1G	Methotrexate	LRAD9225	Update content and signature, remove description	26-Jun
PHR3385-50MG	Disacodyl Related Compound C	LRAD9504	Update content and signature	26-Jun
PHR3871-100MG	Benzalkonium chloride (C18)	LRAD5190	Update content and signature, remove description	2-Jul
PHR3870-100MG	Benzalkonium chloride (C16)	LRAD5189	Update content and signature, remove description	2-Jul
PHR3869-100MG	Benzalkonium chloride (C14)	LRAD5188	Update content and signature, remove description	2-Jul
PHR1969-50MG	Metformin Impurity B	FN06242502	Update retest date	23-Jul
PHR3783-50MG	D-Valganciclovir Hydrochloride	FN07022502	Update retest date	23-Jul

The following new products were recently released

Product No.	Description	API Family
PHR8455-100MG	Bortezomib	Bortezomib
PHR8442-100MG	Varenicline Tartrate	Varenicline
PHR8440-100MG	Dasatinib	Dasatinib
PHR8452-250MG	Deflazacort	Deflazacort
PHR9131-100MG	Ropivacaine Impurity F	Ropivacaine
PHR9346-30MG	Rizatriptan Impurity G	Rizatriptan
PHR2904-50MG	Progesterone Impurity K	Progesterone
PHR9383	Cyclobenzaprine Related Compound B	Cyclobenzaprine; Nortriptyline Hydrochloride
PHR9405-30MG	Moxifloxacin 7-Amino Impurity	Moxifloxacin
PHR9347-30MG	7-(4-(4-(2-bromophenyl)piperazin-1-yl)butoxy)-3,4-dihydroquinolin-2(1H)-one, hydrochloride	Aripiprazole
PHR9221-25MG	Dexamethasone impurity E (17,21-dihydroxy-16α-methylpregna-1,4,9(11)-triene-3,20-dione,)	Dexamethasone
PHR9382-30MG	5-(4-Bromobutoxy)-3,4-dihydroquinolin-2(1H)-one	Aripiprazole
PHR8566-1ML	N-nitroso Salmeterol Solution, 1 mg/mL	Salmeterol
PHR8415-250MG	Apixaban	apixaban
PHR8590-1ML	N-Nitroso-desmethyl-promethazine solution, 1 mg/mL	Promethazine
PHR8686-30MG	Lacosamide Impurity K	Lacosamide
PHR8511-30MG	Buprenorphine Impurity C	Buprenorphine
PHR8594-1ML	N-Nitroso Tamsulosin Solution,  1 mg/mL	Tamsulosin
PHR8658-100MG	R-Ketamine hydrochloride	Ketamine
PHR8966-500MG	Dextroamphetamine Sulfate	Dextroamphetamine
PHR8984-250MG	Lacosamide	Lacosamide
PHR8431-30MG	4-Nitro Lenalidomide	Lenalidomide
PHR8401-15MG	Cefazolin Sodium Impurity A	Cefazolin
PHR8421-100MG	Dabigatran Etexilate MesylateD	abigatran etexilate
PHR8576-1ML	N-Nitroso-Cinacalcet Solution, 1 mg/mL	Cinacalcet
PHR8560-1ML	N-Nitroso paroxetine Solution, 1 mg/mL	Paroxetine
PHR8586-1ML	N-Nitroso Nebivolol Solution, 1 mg/mL	Nebivolol
PHR3931-30MG	Perindopril Related Compound K	Perindopril
PHR8584-100MG	Losartan Related Compound A	Losartan
PHR3924-100MG	Metoprolol Related Compound B	Metoprolol
PHR3478-50MG	Betamethasone Acetate Related Compound D	Betamethasone acetate
PHR9118	Ampicillin Impurity B
PHR9334	Fexofenadine N-oxide
PHR9397	5-(4-(4-(2,3-dichlorophenyl)piperazin-1-yl)butoxy)-3,4-dihydroquinolin-2(1H)-one
95547	L-Norleucine
93822	Salmeterol Related Compound A
68098	Demeton-S-methyl
73887	Tetraethylthiuram disulphide
77072	2-[2,4-Bis(1,2,4-triazol-1-yl)phenyl]-1,3-bis(1,2,4-triazol-1-yl)propan-2-ol
PHR9398-30MG	Aripiprazole Diquinolinone Butanediol	Aripiprazole