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Standard

In the analysis work, it often demanded to apply high-quality compound with the exact content being accurate in order to be compared as the detection control or used to calibrate the instrument, the compound is known as standard sample.
Standard refers to the standard substance used for measuring the potency of biological products. When the production department submits to a higher authority for approval of the quality standard of the biological product, they should also provide the standard sample (indicated in unit (μ)) used for measuring the potency of the tested product.

According to different application, the verification products can be divided into biological standard for the testing of biological products, endocrine drugs, antibiotics and other bioassay and chemical standards including:
1 chemical standards used for calibration of the instrument;
2 chemical reference standards used for calibration of the ultraviolet or infrared spectrum of the drugs;
3 control standards used for the purity test of drugs as well as the impurity control or as the control standards for content determination of the medicine.

In the page 67 of the appendix in the People's Republic of China Pharmacopoeia 1990 1st edition, we can find hundreds kinds of standards including bornyl ester acetate, eugenol and panaxadiol as well as 39 kinds of control medicine for the purify inspection of traditional Chinese medicine, impurity control or the content determination.

International standards
This refers to standard sample, with the potency units of the existing international standard sample potency units as baseline, undergoing further calibration of its potency units on the basis of a wide range of international cooperation. Its potency is expressed in 1U. For a certain product, for the establishment of the first international standard sample, the determination of its potency units should be consulted and decided by the Committee of Experts before the announcement. The international standard is a standard reference substance for worldwide preparation of national standards, so that the international standards can achieve unity.

Reagents and standards
All reagents in the food analysis laboratories should be clearly labeled to indicate the following: 1 name; 2 the date of preparation; 3 Signature from the people in charge; 4 if necessary, we need to add content such as safety and validity and so on.
Most food analysis should use standard sample as reference for qualitative and quantitative determination. The standard sample should be classified according to the following classification methods: 1 international standard; 2 national standards; 3 internal standard; 4 other standards.
Receptacle for reference standards should be clearly affixed to the label, to indicate the following: 1 name; 2 standard document number; 3 Opening times; 4 Validity; 5 Signature.
In addition, the laboratory should keep all the necessary specific files for all the necessary reference standards.
Capacity analysis standard solution should also be strictly managed. It should be clearly posted on all the standard solution containers with labels to indicate: 1 name; 2 concentration; 3 formulation date; 4 No of formulated procedures; 5 storage conditions; 6 validity; 7 Signature from people in charge.

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Structure Chemical Name CAS MF
Fesoterodine Impurity 14 Fesoterodine Impurity 14
Dexamethasone EP impurities E Dexamethasone EP impurities E
(R)-N-((S)-2-aminobutanoyl)-3-(bromomethyl)hexanamide (R)-N-((S)-2-aminobutanoyl)-3-(bromomethyl)hexanamide C11H21BrN2O2
Empagliflozin Impurity 57(R,R) Empagliflozin Impurity 57(R,R)
Azacitidine Impurity 37 Azacitidine Impurity 37 206269-46-7 C8H12N4O5
Aripiprazole peroxide degradation Impurity (MW:303Da) Aripiprazole peroxide degradation Impurity (MW:303Da)
AZITHROMYCIN IMPURITY A AZITHROMYCIN IMPURITY A
Pramipexole Impurity Reference Pramipexole Impurity Reference
2,2'-(4,10-bis((trans)-1,3,4-trihydroxybutan-2-yl)-1,4,7,10-tetraazacyclododecane-1,7-diyl)diacetic acid Gd3+ 2,2'-(4,10-bis((trans)-1,3,4-trihydroxybutan-2-yl)-1,4,7,10-tetraazacyclododecane-1,7-diyl)diacetic acid Gd3+
3-[4-(acetyloxymethyl)phenyl]-2-propenoic acid methyl ester 3-[4-(acetyloxymethyl)phenyl]-2-propenoic acid methyl ester 100688-45-7 C13H14O4
Acetaminophen Impurity 14 Acetaminophen Impurity 14 1991204-56-8 C16H18N2O2
Ketoconazole Impurity 7 Ketoconazole Impurity 7 172032-21-2 C11H12Cl2O3
Rosuvastatin Impurity 59 Rosuvastatin Impurity 59
5-(5-(3-fluoro-4-(methylcarbamoyl)phenyl)-8-oxo-6-thioxo-5,7-diazaspiro[3.4]octan-7-yl)-3-(trifluoromethyl)picolinamide 5-(5-(3-fluoro-4-(methylcarbamoyl)phenyl)-8-oxo-6-thioxo-5,7-diazaspiro[3.4]octan-7-yl)-3-(trifluoromethyl)picolinamide
Losartan Impurity 12 Losartan Impurity 12 727718-93-6 C22H22ClN9
benzyl (2S)-2-amino-3-(4-methanesulfonylphenyl)propanoate hydrochloride benzyl (2S)-2-amino-3-(4-methanesulfonylphenyl)propanoate hydrochloride 1865726-28-8 C17H19NO4S
Glycopyrrolate Impurity 12 Glycopyrrolate Impurity 12 857353-41-4 C13H14O3
(4S,4aR,5R,12aS)-4-(dimethylamino)-3,5,10,11,12a-pentahydroxy-6-methyl-1,12-dioxo-1,4,4a,5,12,12a-hexahydrotetracene-2-carboxamide (4S,4aR,5R,12aS)-4-(dimethylamino)-3,5,10,11,12a-pentahydroxy-6-methyl-1,12-dioxo-1,4,4a,5,12,12a-hexahydrotetracene-2-carboxamide 4660-26-8 C22H22N2O8
9-(1,3-diacetate-2-propoxymethyl)guanine 9-(1,3-diacetate-2-propoxymethyl)guanine 86357-19-9 C13H17N5O6
Cefadroxil Impurity 6 Cefadroxil Impurity 6 2378158-45-1 C32H32N6O9S2
Loratadine Impurity 9 Loratadine Impurity 9 125743-81-9 C22H23ClN2O2
Metronidazole Impurity 1 Metronidazole Impurity 1
Parecoxib Impurity 16 Parecoxib Impurity 16 2235371-89-6 C19H18N2O4S
Rosuvastatin Impurity 54 Rosuvastatin Impurity 54
Regorafenib Impurity 38 Regorafenib Impurity 38
Cefazolin Impurity 28 Cefazolin Impurity 28
4-Isobutylacetophenone (Ibuprofen impurity) 4-Isobutylacetophenone (Ibuprofen impurity)
Acarbose Impurity IV (JP) Acarbose Impurity IV (JP) C13H21NO7
(2S)-Pinocembrin 7-O-[2''-O-(5'''-O-trans
-cinnamoyl)-β-D-apiofuranosyl]-β-D-glucoside (2S)-Pinocembrin 7-O-[2''-O-(5'''-O-trans -cinnamoyl)-β-D-apiofuranosyl]-β-D-glucoside 773899-29-9 C35H36O14
Demethylagrimonolide 6-O-glucoside Demethylagrimonolide 6-O-glucoside 1257408-55-1 C23H26O10
Vonoprazan Impurity 57 Vonoprazan Impurity 57
Tafluprost Impurity 9 Tafluprost Impurity 9 2099033-66-4 C27H41NO8
2H-3-Benzazepin-2-one, 3-[3-[[[(7S)-3,4-dimethoxybicyclo[4.2.0]octa-1,3,5-trien-7-yl]methyl]methylamino]propyl]-1,3,4,5-tetrahydro-5-hydroxy-7,8-dimethoxy- 2H-3-Benzazepin-2-one, 3-[3-[[[(7S)-3,4-dimethoxybicyclo[4.2.0]octa-1,3,5-trien-7-yl]methyl]methylamino]propyl]-1,3,4,5-tetrahydro-5-hydroxy-7,8-dimethoxy- 2253977-80-7 C27H36N2O6
Benzeneacetic acid, 3-[1-hydroxy-4-[4-(hydroxydiphenylmethyl)-1-piperidinyl]butyl]-α,α-dimethyl-, methyl ester Benzeneacetic acid, 3-[1-hydroxy-4-[4-(hydroxydiphenylmethyl)-1-piperidinyl]butyl]-α,α-dimethyl-, methyl ester 1187954-56-8 C33H41NO4
D-Streptamine, O-3-amino-3-deoxy-α-D-glucopyranosyl-(1→6)-O-[6-amino-6-deoxy-α-D-glucopyranosyl-(1→4)]-N1-[(2R)-4-amino-2-hydroxy-1-oxobutyl]-2-deoxy- D-Streptamine, O-3-amino-3-deoxy-α-D-glucopyranosyl-(1→6)-O-[6-amino-6-deoxy-α-D-glucopyranosyl-(1→4)]-N1-[(2R)-4-amino-2-hydroxy-1-oxobutyl]-2-deoxy- 50896-99-6 C22H43N5O13
3-Ethyl 5-Methyl 4-(2-Chlorophenyl)-2-[[2-(1,3-dihydro-1,3-dioxo-2H-isoindol-2-yl)ethoxy]methyl]-6-methyl-3,5-pyridinedicarboxylate 3-Ethyl 5-Methyl 4-(2-Chlorophenyl)-2-[[2-(1,3-dihydro-1,3-dioxo-2H-isoindol-2-yl)ethoxy]methyl]-6-methyl-3,5-pyridinedicarboxylate 331258-36-7 C28H25ClN2O7
N-[2-(methylthio)ethyl]-2-[(3,3,3-trifluoropropyl)thio]-Adenosine 5''-(hydrogen P-1H-imidazol-1-ylphosphonate) N-[2-(methylthio)ethyl]-2-[(3,3,3-trifluoropropyl)thio]-Adenosine 5''-(hydrogen P-1H-imidazol-1-ylphosphonate) 1054332-15-8 C19H25F3N7O6PS2
N-[5-(4-Bromophenyl)-6-[2-(2-pyrimidinyloxy)ethoxy]-4-pyrimidinyl]-N''-propyl-sulfamide N-[5-(4-Bromophenyl)-6-[2-(2-pyrimidinyloxy)ethoxy]-4-pyrimidinyl]-N''-propyl-sulfamide 2211059-00-4 C19H21BrN6O4S
Isomer 1 of Tazobactam Impurity 3 Isomer 1 of Tazobactam Impurity 3
Ceftiofur USP Impurity I Ceftiofur USP Impurity I
Aztreonam Open-Ring Impurity Aztreonam Open-Ring Impurity 102579-58-8 C13H19N5O9S2
Cephalexin Degradation Impurity A Cephalexin Degradation Impurity A
Azlocillin Impurity 8 Azlocillin Impurity 8
Pregabalin-8687(mixture of 4 isomers) Pregabalin-8687(mixture of 4 isomers)
7-(2-chloropropanoyl)-5H-chromeno[2,3-b]pyridin-5-one 7-(2-chloropropanoyl)-5H-chromeno[2,3-b]pyridin-5-one
1-(5H-chromeno[2,3-b]pyridin-7-yl)-2-methoxypropan-1-one 1-(5H-chromeno[2,3-b]pyridin-7-yl)-2-methoxypropan-1-one
(E)-4-chloro-6-(3-(2,4-difluorophenyl)-4-(1H-1,2,4-triazol-1-yl)but-3-en-2-yl)-5-fluoropyrimidine (E)-4-chloro-6-(3-(2,4-difluorophenyl)-4-(1H-1,2,4-triazol-1-yl)but-3-en-2-yl)-5-fluoropyrimidine
Dolutegravir Impurity C Dolutegravir Impurity C 1802141-49-6 C22H23F2N3O5
Adefovir Dipivoxil Impurity 24 Adefovir Dipivoxil Impurity 24 116384-58-8 C14H23O7PS
Dapoxetine Impurity 68 Dapoxetine Impurity 68 119357-48-1 C19H18O
Tobramycin Impurity Tobramycin Impurity 74501-86-3 C18H35N5O8
Peramivir Impurity 24 Peramivir Impurity 24
2-CHLORO-6-AMINO-9-(2',3',5'-TRI-O-ACETYL--D-RIBOFURANOSYL)PURINE 2-CHLORO-6-AMINO-9-(2',3',5'-TRI-O-ACETYL--D-RIBOFURANOSYL)PURINE 79999-39-6 C16H18ClN5O7
3,4-Dihydro-7-(4-chlorobutoxy)-2(1H)-quinolinone 3,4-Dihydro-7-(4-chlorobutoxy)-2(1H)-quinolinone 120004-79-7 C13H16ClNO2
Vonoprazan Fumarate Impurity 6 Vonoprazan Fumarate Impurity 6 2250243-23-1 C33H27F2N5O4S2
3-((3aS,4R,6S,6aR)-6-(2-hydroxyethoxy)-2,2-dimethyltetrahydro- 4H-cyclopenta[d][1,3]dioxol-4-yl)-5-(propylthio)-3H-[1,2,3] triazolo[4,5-d]pyrimidin-7-ol 3-((3aS,4R,6S,6aR)-6-(2-hydroxyethoxy)-2,2-dimethyltetrahydro- 4H-cyclopenta[d][1,3]dioxol-4-yl)-5-(propylthio)-3H-[1,2,3] triazolo[4,5-d]pyrimidin-7-ol 1456538-51-4 C17H25N5O5S
Esomeprazole Impurity 24 Esomeprazole Impurity 24
Prasugrel Impurity 15 Prasugrel Impurity 15
Pregabalin Impurity 18 Pregabalin Impurity 18 1621171-19-4 C9H15NO2
Pregabalin Impurity 23 Pregabalin Impurity 23
Butylphthalide impurity Butylphthalide impurity 16692-58-3 C12H14O2
ethyl 2,5-dihydroxybenzenesulfonate ethyl 2,5-dihydroxybenzenesulfonate C8H10O5S
5-ALLYLIDENE-10,11-DIHYDRO-5H-DIBENZO[A,D]CYCLOHEPTENE 5-ALLYLIDENE-10,11-DIHYDRO-5H-DIBENZO[A,D]CYCLOHEPTENE 24755-73-5 C18H16
tert-butyl (4-(benzyloxy)-8-methylnaphthalen-2-yl)carbamate tert-butyl (4-(benzyloxy)-8-methylnaphthalen-2-yl)carbamate 1662687-76-4 C23H25NO3
Nintedanib Impurity 27 Nintedanib Impurity 27
ethyl 2-(2-formyl-3-hydroxyphenyl)-4-methylthiazole-5- carboxylate ethyl 2-(2-formyl-3-hydroxyphenyl)-4-methylthiazole-5- carboxylate C14H13NO4S
LUMAT-004 LUMAT-004 313544-31-9 C16H17N3O3
Varenicline Impurity 3 Varenicline Impurity 3 1333145-89-3 C14H15N3
Econazole Related Compound C (15 mg) (1-(4-Chlorobenzyl)-3-[(2RS)-2-[(4-chlorobenzyl)oxy]-2-(2,4-dichlorophenyl)ethyl]imidazolium chloride) Econazole Related Compound C (15 mg) (1-(4-Chlorobenzyl)-3-[(2RS)-2-[(4-chlorobenzyl)oxy]-2-(2,4-dichlorophenyl)ethyl]imidazolium chloride) 57265-33-5
Amlodipine Impurity 22 (Z-Isomer) Amlodipine Impurity 22 (Z-Isomer) C26H31ClN2O8S
Amlodipine Impurity 28 Amlodipine Impurity 28 79781-21-8 C18H20ClNO5
Axitinib Impurity 16 Axitinib Impurity 16
Axitinib Impurity 22 Axitinib Impurity 22
Imidazo[5,1-f][1,2,4]triazin-4(1H)-one, 2-[2-ethoxy-5-[(4-ethyl-4-oxido-1-piperazinyl)sulfonyl]phenyl]-5-methyl-7-propyl- Imidazo[5,1-f][1,2,4]triazin-4(1H)-one, 2-[2-ethoxy-5-[(4-ethyl-4-oxido-1-piperazinyl)sulfonyl]phenyl]-5-methyl-7-propyl- 448184-48-3 C23H32N6O5S
Dolutegravir 4-Desfluoro Impurity Dolutegravir 4-Desfluoro Impurity 1863916-87-3 C20H20FN3O5
Tetrabenazine Dehydro Impurity Tetrabenazine Dehydro Impurity 100322-43-8 C19H25NO3
Cefotiam Impurity 22 Cefotiam Impurity 22 1628441-07-5 C13H14N4O5S2
Dezocine Impurity 2 Dezocine Impurity 2 100667-17-2 C16H21NO
loteprednol Impurity 7 loteprednol Impurity 7 82034-20-6 C24H33ClO7
Sitagliptin Impurity 28 Sitagliptin Impurity 28 898543-70-9 C32H25F12N9O2
Vilanterol Impurity 3 Triphenylacetate Vilanterol Impurity 3 Triphenylacetate 503070-62-0 C23H31Cl2NO5
Empagliflozin Impurity 33 Empagliflozin Impurity 33
Sugammadex Impurity 21 Sugammadex Impurity 21 2412952-93-1 C72H113NaO48S8
4-((1,4,8,11-tetraazacyclotetradecan-1-yl)methyl)benzaldehyde trihydrochloride 4-((1,4,8,11-tetraazacyclotetradecan-1-yl)methyl)benzaldehyde trihydrochloride 1254176-45-8 C18H30N4O
Remifentanil Impurity 1 (RTF-02) Remifentanil Impurity 1 (RTF-02) 938184-94-2 C16H21N3O2
methyl (3aS,4R,6S,6aR)-4-((tert-butoxycarbonyl)amino)-3-(pentan-3-yl)-3a,5,6,6a-tetrahydro-4H-cyclopenta[d]isoxazole-6-carboxylate methyl (3aS,4R,6S,6aR)-4-((tert-butoxycarbonyl)amino)-3-(pentan-3-yl)-3a,5,6,6a-tetrahydro-4H-cyclopenta[d]isoxazole-6-carboxylate 383910-25-6 C18H30N2O5
sodium (((((R)-1-(6-amino-9H-purin-9-yl)propan-2-yl)oxy) methyl)oxidophosphoryl)-L-alaninate sodium (((((R)-1-(6-amino-9H-purin-9-yl)propan-2-yl)oxy) methyl)oxidophosphoryl)-L-alaninate 382140-24-1 C12H19N6O5P
N-Des-tetrahydrofuran N-(6,7-Dimethoxy-4,4a-dihydroquinazolin-4-amine) Alfuzosin N-Des-tetrahydrofuran N-(6,7-Dimethoxy-4,4a-dihydroquinazolin-4-amine) Alfuzosin 928780-95-4 C24H30N8O4
Zopiclone Impurity 13 Zopiclone Impurity 13
N-METHYLISATIN N-METHYLISATIN 2058-74-4 C9H7NO2
1-bromo-3-(4-ethoxybenzyl)benzene 1-bromo-3-(4-ethoxybenzyl)benzene 898538-17-5 C15H15BrO
(2S,3R,4R,5S,6R)-2-(4-chloro-3-((4-ethoxyphenyl)(methoxy) methyl)phenyl)-6-(hydroxymethyl)tetrahydro-2H-pyran-3,4,5-triol (2S,3R,4R,5S,6R)-2-(4-chloro-3-((4-ethoxyphenyl)(methoxy) methyl)phenyl)-6-(hydroxymethyl)tetrahydro-2H-pyran-3,4,5-triol 1318794-28-3 C22H27ClO7
Brivaracetam Impurity Brivaracetam Impurity 2432911-37-8 C11H22O3
Azithromycin EP Impurity K Azithromycin EP Impurity K
Evogliptin Impurity 1 Evogliptin Impurity 1
Ondansetron IMpurity 5 Ondansetron IMpurity 5
Plerixafor Impurity 1 Plerixafor Impurity 1
MeropeneM iMpurity 7 MeropeneM iMpurity 7
Afatinib Impurity 50 Afatinib Impurity 50
Brexpiprazole Impurity 34 Brexpiprazole Impurity 34 2247155-42-4 C25H27N3O4S
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