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
5-Pyrimidinamine, 4,6-dichloro-N-hydroxy-2-(propylthio)- 5-Pyrimidinamine, 4,6-dichloro-N-hydroxy-2-(propylthio)- 2517939-84-1 C7H9Cl2N3OS
(R)-4-(4-methyl-6-oxo-1,4,5,6-tetrahydropyridazin-3-yl)benzenediazonium   tetrafluoroborate (R)-4-(4-methyl-6-oxo-1,4,5,6-tetrahydropyridazin-3-yl)benzenediazonium tetrafluoroborate 1630761-21-5 C11H11N4O+
8-chloro-11-(1-((5-methylpyridin-3-yl)methyl)piperidin-4-ylidene)-6,11-dihydro-5H-benzo[5,6]cyclohepta[1,2-b]pyridine 1-oxide 8-chloro-11-(1-((5-methylpyridin-3-yl)methyl)piperidin-4-ylidene)-6,11-dihydro-5H-benzo[5,6]cyclohepta[1,2-b]pyridine 1-oxide
N-acetyl-β-D-glucosidase N-acetyl-β-D-glucosidase
2-(4-carboxypiperidin-1-yl)-3-chloro-5-((4-(4-chlorothiophen-2-yl)-5-(4-cyclohexylpiperazin-1-yl)thiazol-2-yl)carbamoyl)pyridine 1-oxide 2-(4-carboxypiperidin-1-yl)-3-chloro-5-((4-(4-chlorothiophen-2-yl)-5-(4-cyclohexylpiperazin-1-yl)thiazol-2-yl)carbamoyl)pyridine 1-oxide
2H-Naphtho[1,2-b]pyran-6-ol, 2,5-dimethyl-2-[(3E,7E)-4,8,12-trimethyl-3,7,11-tridecatrienyl]- (9CI) 2H-Naphtho[1,2-b]pyran-6-ol, 2,5-dimethyl-2-[(3E,7E)-4,8,12-trimethyl-3,7,11-tridecatrienyl]- (9CI) 65941-19-7 C31H40O2
Amifostine Impurity 15 Amifostine Impurity 15 10297-31-1 C7H17Br3N2
Doxylamine Impurity G Doxylamine Impurity G
Afatinib Impurity OLQ Afatinib Impurity OLQ
Androstane-3,17-diol,2-(4-morpholinyl)-16-(1-pyrrolidinyl) Androstane-3,17-diol,2-(4-morpholinyl)-16-(1-pyrrolidinyl) 119302-22-6 C31H50N2O5
Landiolol impurity W Landiolol impurity W
Metoprolol IMpurity T Metoprolol IMpurity T C15H25NO3
Teneligliptin Impurity 11 Teneligliptin Impurity 11 2131105-24-1 C25H35N5O4
Teneligliptin Impurity 16 Teneligliptin Impurity 16
IMP-EP-M IMP-EP-M 1193104-80-1 C60H79N2O15S+
Hyoscine Butylbromide EP Impurity H Hyoscine Butylbromide EP Impurity H
2-((4S,6S)-6-(2-aminoethyl)-2,2-dimethyl-1,3-dioxan-4-yl)acetic acid 2-((4S,6S)-6-(2-aminoethyl)-2,2-dimethyl-1,3-dioxan-4-yl)acetic acid 2165770-84-1 C10H19NO4
Androstane-2,17-diol, 3-(4-morpholinyl)-16-(1-pyrrolidinyl)-, (2α,3β,5α,16β,17β)- Androstane-2,17-diol, 3-(4-morpholinyl)-16-(1-pyrrolidinyl)-, (2α,3β,5α,16β,17β)- 1252016-49-1 C27H46N2O3
N-(2-HYDROXYETHYL)ISONICOTINAMIDE, 99 N-(2-HYDROXYETHYL)ISONICOTINAMIDE, 99 6265-74-3 C8H10N2O2
BENAZEPRIL RELATED COMPOUND G (15 MG) ((3-(1 -ETHOXYCARBONYL-3-PHENYL-(1 S)-PROPYL)AMINO-2,3,4,5-TETRAHYDRO-2-OXO-1H-1-(3S)-BENZAZE-PINE)-1-ACETIC ACID, ETHYL ESTER) BENAZEPRIL RELATED COMPOUND G (15 MG) ((3-(1 -ETHOXYCARBONYL-3-PHENYL-(1 S)-PROPYL)AMINO-2,3,4,5-TETRAHYDRO-2-OXO-1H-1-(3S)-BENZAZE-PINE)-1-ACETIC ACID, ETHYL ESTER) 103129-58-4 C26H32N2O5
CLOPIDOGREL  RELATED  COMPOUND  C  (20 MG) (METHYL (-)-(R)-(O-CHLOROPHENYL)-6,7-DIHYDROTHIE-NO[3,2-C]PYRIDINE-5(4H)-ACETATE,  HYDROGEN SUL- FATE) CLOPIDOGREL RELATED COMPOUND C (20 MG) (METHYL (-)-(R)-(O-CHLOROPHENYL)-6,7-DIHYDROTHIE-NO[3,2-C]PYRIDINE-5(4H)-ACETATE, HYDROGEN SUL- FATE) 120202-71-3 C16H18ClNO6S2
(S)-N,N-dimethyl-3-((R)-3-(naphthalen-1-yloxy)-1-phenylpropoxy)-1-phenylpropan-1-amine (S)-N,N-dimethyl-3-((R)-3-(naphthalen-1-yloxy)-1-phenylpropoxy)-1-phenylpropan-1-amine C30H33NO2
ETHYL 4-CHLORO-2-HYDROXYIMINO-3-OXO-BUTYRATE ETHYL 4-CHLORO-2-HYDROXYIMINO-3-OXO-BUTYRATE 66338-95-2 C6H8ClNO4
2-((R)-3-(diisopropylamino)-1-phenylpropyl)-4-(1-hydroxyethyl)phenyl isobutyrate 2-((R)-3-(diisopropylamino)-1-phenylpropyl)-4-(1-hydroxyethyl)phenyl isobutyrate C27H39NO3
NA NA
Palbociclib impurity LAAP Palbociclib impurity LAAP
(R)-N-((S)-1-amino-1-oxobutan-2-yl)-3-((((S)-1-amino-1-oxobutan-2-yl)amino)methyl)hexanamide (R)-N-((S)-1-amino-1-oxobutan-2-yl)-3-((((S)-1-amino-1-oxobutan-2-yl)amino)methyl)hexanamide C15H30N4O3
Dapagliflozin Impurity 32 Dapagliflozin Impurity 32 1528636-07-8 C22H27ClO7
1,1'-(1,4-phenylenebis(methylene))bis(1,4,8,11-tetraazacyclotetradecane 1-oxide) 1,1'-(1,4-phenylenebis(methylene))bis(1,4,8,11-tetraazacyclotetradecane 1-oxide) C28H54N8O2
N-(2-amino-6-oxo-3,6-dihydropyrimidin-4-yl)- N-(2-amino-6-oxo-3,6-dihydropyrimidin-4-yl)-
Droxidopa Impurity 6 Droxidopa Impurity 6 90044-46-5 C16H15NO4
Osimertinib Impurity 2 DiHCl Osimertinib Impurity 2 DiHCl
Dofetilide Impurity B Dofetilide Impurity B
Sugammadex Monohydroxy Impurity Sugammadex Monohydroxy Impurity
Cyclic Macitentan quarternary salt Impurity Cyclic Macitentan quarternary salt Impurity
Lacosamide Impurity – K Lacosamide Impurity – K
Cefdinir CP Impurity I&J&K&L Cefdinir CP Impurity I&J&K&L
Dapoxetine Impurity 41 Dapoxetine Impurity 41
Doxofylline Impurity 16 Doxofylline Impurity 16
Olopatadine Impurity 5 Olopatadine Impurity 5 55690-18-1 C17H16O5
Taladafil Impurity 38 Taladafil Impurity 38
Salbutamol impurity 41 Salbutamol impurity 41
Gadobutrol Impurity 20 Gadobutrol Impurity 20
Dapagliflozin Impurity 48 Dapagliflozin Impurity 48 2069934-29-6 C15H14Cl2O
Cilostazol Impurity I Cilostazol Impurity I
Pramipexole DBTA Impurity Pramipexole DBTA Impurity 1821389-09-6 C7H8N2S
Amoxicillin Oxidized Impurities Amoxicillin Oxidized Impurities
TERBUTALINE IMPURITY C TERBUTALINE IMPURITY C 139508-58-0 C12H17NO3
ZIDOVUDINE IMPURITY B ZIDOVUDINE IMPURITY B
Acetamide, N-[2-hydroxy-3-[4-[[2-(1-methylethoxy)ethoxy]methyl]phenoxy]propyl]-N-(1-methylethyl)- Acetamide, N-[2-hydroxy-3-[4-[[2-(1-methylethoxy)ethoxy]methyl]phenoxy]propyl]-N-(1-methylethyl)- 66722-65-4 C20H33NO5
Pyrimidine, 4-bromo-6-(1-bromoethyl)-5-fluoro- Pyrimidine, 4-bromo-6-(1-bromoethyl)-5-fluoro- 1307315-02-1 C6H5Br2FN2
4-(3,4-dichlorophenyl)-N-methyl-3,4-dihydro-2H-naphthalen-1-imine oxide 4-(3,4-dichlorophenyl)-N-methyl-3,4-dihydro-2H-naphthalen-1-imine oxide 209473-00-7 C17H15Cl2NO
Tazobactam Impurity EBT Tazobactam Impurity EBT
Mixture of Cefoxitin Impurities E&F Mixture of Cefoxitin Impurities E&F
Ambrisentan Impurity E Ambrisentan Impurity E 1312092-82-2 C21H18N2O3
3-[(Dimethylamino)methyl]-9-methyl-1,2,3,9-tetrahydro-4H-carbazol-4-one 3-[(Dimethylamino)methyl]-9-methyl-1,2,3,9-tetrahydro-4H-carbazol-4-one 153139-56-1 C16H20N2O
Roxithromycin Impurity K Roxithromycin Impurity K
Bepotastine N-Oxide Impurity Bepotastine N-Oxide Impurity
Nintedanib Impurity 25 Nintedanib Impurity 25
Tripterygium glycosides Tripterygium glycosides
(RS)-3-tert-butyl 4-ethyl thiazolidine-3,4-dicarboxylate (RS)-3-tert-butyl 4-ethyl thiazolidine-3,4-dicarboxylate C11H19NO4S
2-(3-(4-(7H-Pyrrolo[2,3-d]pyrimidin-2-yl)-1H-pyrazol-1-yl)-1-(ethylsulfonyl)azetidin-3-yl)acetonitrile 2-(3-(4-(7H-Pyrrolo[2,3-d]pyrimidin-2-yl)-1H-pyrazol-1-yl)-1-(ethylsulfonyl)azetidin-3-yl)acetonitrile C16H17N7O2S
6-BENZYLAMINOPURINE 9-(§-D-GLUCOSIDE) 6-BENZYLAMINOPURINE 9-(§-D-GLUCOSIDE)
Ipragliflozin Impurity 4 Ipragliflozin Impurity 4
Mupirocin iMpurity 6 Mupirocin iMpurity 6 C26H44O9
Vitamin B1 Impurity 5 Vitamin B1 Impurity 5 2443-50-7 C12H17ClN4OS
Irbesartan IMpurity 16 Irbesartan IMpurity 16 C25H28N6O
479348-49-7 479348-49-7 479348-49-7 C20H19FN2O6
1449029-77-9 1449029-77-9 1449029-77-9 C29H26N4O7
295366-48-2 295366-48-2 295366-48-2 C17H25NO3
(3S,4R)-phenyl 3-((benzo[d][1,3]dioxol-5-yloxy)methyl)-4-phenyl piperidine-1-carboxylate (3S,4R)-phenyl 3-((benzo[d][1,3]dioxol-5-yloxy)methyl)-4-phenyl piperidine-1-carboxylate C26H25NO5
Fluticasone Impurity 13 Fluticasone Impurity 13 C25H31F3O5S
nicergoline impurity K nicergoline impurity K
Clopidogrel Impurity 46 Clopidogrel Impurity 46 1801260-21-8 C25H26ClNO6S
Rosuvastatin Impurity 89 Rosuvastatin Impurity 89 2226413-61-0 C38H46F2N6O9S2
Ibuprofen EP Impurity I Ibuprofen EP Impurity I 2143535-26-4 C13H18O2
Moxifloxacin Impurity 11 Moxifloxacin Impurity 11
Linagliptin Impurity 7 Linagliptin Impurity 7 2416949-69-2 C25H29N7O4
Tofacitinib Related Compound 16 Tofacitinib Related Compound 16 2183519-70-0 C15H23N5
Vortioxetine Impurity 8 Vortioxetine Impurity 8
Erlotinib Impurity 21 Erlotinib Impurity 21
Fluvastatin EP Impurity C Fluvastatin EP Impurity C 779995-42-5 C24H26FNO4
Oseltamivir Impurity 17 Oseltamivir Impurity 17 2413185-88-1 C14H22O4
Topiroxostat Impurity 15 Topiroxostat Impurity 15
Teneligliptin Impurity 10 Di-Trifluoroacetate Teneligliptin Impurity 10 Di-Trifluoroacetate
Posaconazole iMpurity 68 Posaconazole iMpurity 68
Erlotinib Hydrochloride iMpurity 50 Erlotinib Hydrochloride iMpurity 50
(S)-methyl 9,10-difluoro-3-methyl-7-oxo-3,7-dihydro-2H-[1,4]oxazino [2,3,4-ij]quinoline-6-carboxylate (S)-methyl 9,10-difluoro-3-methyl-7-oxo-3,7-dihydro-2H-[1,4]oxazino [2,3,4-ij]quinoline-6-carboxylate 1213269-49-8 C14H11F2NO4
Vonoprazan Impurity U3 Vonoprazan Impurity U3
Prucalopride Impurity 10/ethyl 4-(4-amino-5-chloro-2,3-dihydrobenzofuran-7-carboxamido)piperidine-1-carboxylate Prucalopride Impurity 10/ethyl 4-(4-amino-5-chloro-2,3-dihydrobenzofuran-7-carboxamido)piperidine-1-carboxylate 137211-63-3 C17H22ClN3O4
Faropenem Degradation Impurity 4 Faropenem Degradation Impurity 4
7-(2-hydroxy-1,1-dimethoxypropyl)-5H-chromeno[2,3-b]pyridin-5-ol 7-(2-hydroxy-1,1-dimethoxypropyl)-5H-chromeno[2,3-b]pyridin-5-ol
2-chloro-1-(5-methoxy-5H-chromeno[2,3-b]pyridin-7-yl)propan-1-one 2-chloro-1-(5-methoxy-5H-chromeno[2,3-b]pyridin-7-yl)propan-1-one
Oxacillin Impurity 3 Oxacillin Impurity 3 21106-64-9 C19H18ClN3O5S
Latanoprost Impurity 3 Latanoprost Impurity 3 2278245-92-2 C27H41BrO5
Ethyl 2-(2-Iodoethoxy)acetate Ethyl 2-(2-Iodoethoxy)acetate 56703-25-4 C6H11IO3
6,8-DIBROMO-3-CYCLOHEXYL-3,4-DIHYDRO-2(1H)-QUINAZOLINONE 6,8-DIBROMO-3-CYCLOHEXYL-3,4-DIHYDRO-2(1H)-QUINAZOLINONE 21237-84-3 C14H16Br2N2O
DESTHIAZOLYLMETHYL RITONAVIR DESTHIAZOLYLMETHYL RITONAVIR 256328-82-2 C33H43N5O4S
S-DIDEMETHYL CITALOPRAM S-DIDEMETHYL CITALOPRAM 166037-78-1 C18H17FN2O
METHOTREXATE DIMETHYL ESTER METHOTREXATE DIMETHYL ESTER 34378-65-9 C22H26N8O5
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