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
Benzoic acid, 2-(1',6'-dihydro-6'-oxo-1'-phenyl[2,3'-bipyridin]-5'-yl)-, methyl ester Benzoic acid, 2-(1',6'-dihydro-6'-oxo-1'-phenyl[2,3'-bipyridin]-5'-yl)-, methyl ester 543699-60-1 C24H18N2O3
1-(4-NITRO-PHENYL)-PIPERIDIN-2-ONE 1-(4-NITRO-PHENYL)-PIPERIDIN-2-ONE 39257-91-5 C5H10O2S
Atomoxetine impurity D CRS Atomoxetine impurity D CRS 873310-29-3 C17H21NO
Beraprost Impurity 2 Beraprost Impurity 2
Brivudine Impurity 2 Brivudine Impurity 2
3-METHOXYCARBONYLAMINO-4-METHYLPYRIDINE 3-METHOXYCARBONYLAMINO-4-METHYLPYRIDINE 694495-63-1 C8H10N2O2
4-chloro-6-(1-(6-ethyl-5-fluoropyrimidin-4-yl)ethyl)-5-fluoropyrimidine 4-chloro-6-(1-(6-ethyl-5-fluoropyrimidin-4-yl)ethyl)-5-fluoropyrimidine
Empagliflozin Impurity 74 Empagliflozin Impurity 74
Empagliflozin Impurity 78 Empagliflozin Impurity 78
Empagliflozin Impurity 85 Empagliflozin Impurity 85
Relugolix Impurity 11 Relugolix Impurity 11
(8S,16S,Z)-16-amino-5-(2-aminothiazol-4-yl)-11-imino-2,2-dimethyl-6,9-dioxo-8-((S)-1-(sulfoamino)ethyl)-3-oxa-4,7,10,12-tetraazaheptadec-4-ene-1,17-dioic acid (8S,16S,Z)-16-amino-5-(2-aminothiazol-4-yl)-11-imino-2,2-dimethyl-6,9-dioxo-8-((S)-1-(sulfoamino)ethyl)-3-oxa-4,7,10,12-tetraazaheptadec-4-ene-1,17-dioic acid
1-(3,4-bis(hydroxymethyl)-1H-pyrrol-2-yl)ethan-1-one 1-(3,4-bis(hydroxymethyl)-1H-pyrrol-2-yl)ethan-1-one
Gadobutrol Impurity 32 Gadobutrol Impurity 32 C14H23GdN4O6
Olmesartan Medoxomil Impurity 28 Olmesartan Medoxomil Impurity 28 1127249-17-5 C14H10Br2N4
Ornidazole Impurity 23 Ornidazole Impurity 23 1100750-18-2
Olanzapine impurity CNB Olanzapine impurity CNB
Pitavastatin Impurity 74 Pitavastatin Impurity 74 167934-30-7 C29H30FNO4
Etoricoxib Impurity 35 Etoricoxib Impurity 35 855307-79-8 C18H13ClN2O2S
Febuxostat Impurity 102 Febuxostat Impurity 102
Ticagrelor Impurity 131 Ticagrelor Impurity 131
door bird impurities door bird impurities
Topiroxostat Impurity 41 Topiroxostat Impurity 41
1-((2R,3R)-3-(4-(4-cyanophenyl)thiazol-2-yl)-2-(2,5-difluorophenyl)-2-hydroxybutyl)-4-(1-((methyl(3-((2-(methylamino)acetoxy)methyl)pyridin-1-oxide-2-yl)carbamoyl)oxy)ethyl)-1H-1,2,4-triazol-4-ium 1-((2R,3R)-3-(4-(4-cyanophenyl)thiazol-2-yl)-2-(2,5-difluorophenyl)-2-hydroxybutyl)-4-(1-((methyl(3-((2-(methylamino)acetoxy)methyl)pyridin-1-oxide-2-yl)carbamoyl)oxy)ethyl)-1H-1,2,4-triazol-4-ium
2-Piperidinecarboxylic acid, 1-formyl-, (1S,2R,3S,6R,7E,10S,12S)-3-hydroxy-1-[(1E)-2-[(1R,3R,4R)-4-hydroxy-3-methoxycyclohexyl]-1-methylethenyl]-12-methoxy-2,8,10-trimethyl-5-oxo-6-(2-propen-1-yl)-12-[(2R,3S,5R)-tetrahydro-3-methoxy-5-methyl-6-oxo-2H-pyran-2-yl]-7-dodecen-1-yl ester, (2S)- 2-Piperidinecarboxylic acid, 1-formyl-, (1S,2R,3S,6R,7E,10S,12S)-3-hydroxy-1-[(1E)-2-[(1R,3R,4R)-4-hydroxy-3-methoxycyclohexyl]-1-methylethenyl]-12-methoxy-2,8,10-trimethyl-5-oxo-6-(2-propen-1-yl)-12-[(2R,3S,5R)-tetrahydro-3-methoxy-5-methyl-6-oxo-2H-pyran-2-yl]-7-dodecen-1-yl ester, (2S)- 143210-33-7 C43H69NO11
Blonanserin Impurity 15 Blonanserin Impurity 15 143213-96-1 C17H17ClFNO
1H-Pyrazole-1-propanoic acid, β-cyclopentyl-4-(7H-pyrrolo[2,3-d]pyrimidin-4-yl)-, (βR)- 1H-Pyrazole-1-propanoic acid, β-cyclopentyl-4-(7H-pyrrolo[2,3-d]pyrimidin-4-yl)-, (βR)- 2102675-40-9 C17H19N5O2
(2S,5R)-2-carbamoyl-7-oxo-1,6-diazabicyclo[3.2.1]octan-6-yl ethyl sulfate (2S,5R)-2-carbamoyl-7-oxo-1,6-diazabicyclo[3.2.1]octan-6-yl ethyl sulfate
sodium ((S)-4-(4-(2-(2-amino-4-oxo-4,7-dihydro-1H-pyrrolo[2,3-d] pyrimidin-5-yl)ethyl)benzamido)-4-carboxylatobutanoyl)-L-glutamate sodium ((S)-4-(4-(2-(2-amino-4-oxo-4,7-dihydro-1H-pyrrolo[2,3-d] pyrimidin-5-yl)ethyl)benzamido)-4-carboxylatobutanoyl)-L-glutamate
1H-Purin-2-amine, 6,9-dihydro-9-[(1S,3R,4S)-2-methylene-4-(phenylmethoxy)-3-[(phenylmethoxy)methyl]cyclopentyl]-6-(phenylmethoxy)-N-(triphenylmethyl)- 1H-Purin-2-amine, 6,9-dihydro-9-[(1S,3R,4S)-2-methylene-4-(phenylmethoxy)-3-[(phenylmethoxy)methyl]cyclopentyl]-6-(phenylmethoxy)-N-(triphenylmethyl)- 2097265-84-2 C52H49N5O3
6,6'-oxybis(3-((4-oxo-3,4-dihydrophthalazin-1-yl)methyl)benzonitrile) 6,6'-oxybis(3-((4-oxo-3,4-dihydrophthalazin-1-yl)methyl)benzonitrile)
Glycine, N-[(1-ethyl-4-hydroxy-7-phenoxy-3-isoquinolinyl)carbonyl]- Glycine, N-[(1-ethyl-4-hydroxy-7-phenoxy-3-isoquinolinyl)carbonyl]- 808120-20-9 C20H18N2O5
Vonoprazan Impurity 55 Vonoprazan Impurity 55
N-(5-((diphenylphosphoryl)methyl)-4-(2-fluorophenyl)-6-isopropylpyrimidin-2-yl)-N-methylmethanesulfonamide N-(5-((diphenylphosphoryl)methyl)-4-(2-fluorophenyl)-6-isopropylpyrimidin-2-yl)-N-methylmethanesulfonamide
Ethane, 1,1,1-trichloro-2,2,2-trimethoxy- Ethane, 1,1,1-trichloro-2,2,2-trimethoxy- 19932-79-7 C5H9Cl3O3
Budesonide Impurity 29 Budesonide Impurity 29
Budesonide Impurity 20 Budesonide Impurity 20
5-Hexenoic acid, 4-(acetylamino)- 5-Hexenoic acid, 4-(acetylamino)- 1824506-31-1 C8H13NO3
Glycine, N-[(4-methylphenyl)sulfonyl]glycyl-, ethyl ester Glycine, N-[(4-methylphenyl)sulfonyl]glycyl-, ethyl ester 2478-45-7 C13H18N2O5S
Pneumocandin B0, 1-[(4R,5S)-5-[(2-aminoethyl)amino]-N2-[(10R,12S)-10,12-dimethyl-1-oxotetradecyl]-4-hydroxy-L-ornithine]- Pneumocandin B0, 1-[(4R,5S)-5-[(2-aminoethyl)amino]-N2-[(10R,12S)-10,12-dimethyl-1-oxotetradecyl]-4-hydroxy-L-ornithine]- 1404083-47-1 C52H86N10O16
1-Pyrrolidinehexanoic acid, 2-ethenyl-γ,5-dioxo- 1-Pyrrolidinehexanoic acid, 2-ethenyl-γ,5-dioxo- 2512190-67-7 C12H17NO4
2-Piperidinone, 3-chloro-1-(4-nitrophenyl)- 2-Piperidinone, 3-chloro-1-(4-nitrophenyl)- 2512213-45-3 C11H11ClN2O3
Avatrombopag Impurity 40 Avatrombopag Impurity 40
(E)-3-(4-((3-(1-(4-((1H-imidazol-1-yl)methyl)phenyl)-2-carboxyethyl)-1H-imidazol-3-ium-1-yl)methyl)phenyl)acrylate (E)-3-(4-((3-(1-(4-((1H-imidazol-1-yl)methyl)phenyl)-2-carboxyethyl)-1H-imidazol-3-ium-1-yl)methyl)phenyl)acrylate
Cisatracurium besylate impurity 21 Cisatracurium besylate impurity 21
Dacomitinib Impurity Dacomitinib Impurity
6-O-DESMETHYL DONEPEZIL 6-O-DESMETHYL DONEPEZIL 120013-56-1 C23H27NO3
2-(2-METHYL-4-NITRO-IMIDAZOL-1-YL)-ETHANOL 2-(2-METHYL-4-NITRO-IMIDAZOL-1-YL)-ETHANOL 705-19-1 C6H9N3O3
N,N-bis((5-(2-fluorophenyl)-1H-pyrrol-3-yl)methyl)pyridine-3-sulfonamide N,N-bis((5-(2-fluorophenyl)-1H-pyrrol-3-yl)methyl)pyridine-3-sulfonamide 2514957-29-8 C27H22F2N4O2S
2,4(1H,3H)-Pyrimidinedione, 1-β-L-ribofuranosyl-, 4-oxime (9CI) 2,4(1H,3H)-Pyrimidinedione, 1-β-L-ribofuranosyl-, 4-oxime (9CI) 402725-23-9 C9H13N3O6
1H-Indole-2-sulfonic acid, 6-hydroxy-1-methyl- 1H-Indole-2-sulfonic acid, 6-hydroxy-1-methyl- 2271443-87-7 C9H9NO4S
methyl 4-hydroxy-2-oxopyrrolidine-1-acetate methyl 4-hydroxy-2-oxopyrrolidine-1-acetate 85614-52-4 C7H11NO4
5-[ethyl(2-hydroxyethyl)amino]pentan-2-one 5-[ethyl(2-hydroxyethyl)amino]pentan-2-one 74509-79-8 C9H19NO2
Sitagliptin EP Impurity 5 Sitagliptin EP Impurity 5
Simvastatin Impurity 6 Simvastatin Impurity 6
colocynthin colocynthin 1398-78-3 C38H54O13
Anastrozole Impurity 14 Anastrozole Impurity 14
Pemetrexed Impurity 42 Pemetrexed Impurity 42
2-(6-Aminopurin-9-yl)ethanol 2-(6-Aminopurin-9-yl)ethanol 707-99-3 C7H9N5O
9-Azabicyclo[3.3.1]Nonane-9-Acetic Acid, 3-(Ethoxycarbonyl)-7-Oxo-, Ethyl Ester 9-Azabicyclo[3.3.1]Nonane-9-Acetic Acid, 3-(Ethoxycarbonyl)-7-Oxo-, Ethyl Ester 115956-03-1 C15H23NO5
Cefathiamidine Impurity F Cefathiamidine Impurity F
1-(Bromophenylmethyl)-4-chlorobenzene 1-(Bromophenylmethyl)-4-chlorobenzene 948-54-9 C13H10BrCl
Flomoxef oxidation impurities Flomoxef oxidation impurities
Toltrazuril Impurity 1 Toltrazuril Impurity 1
((2R,3R,5S)-5-(4-amino-2-oxopyrimidin-1(2H)-yl)-4,4-difluoro-3-hydroxytetrahydrofuran-2-yl)methyl benzoate ((2R,3R,5S)-5-(4-amino-2-oxopyrimidin-1(2H)-yl)-4,4-difluoro-3-hydroxytetrahydrofuran-2-yl)methyl benzoate
Aprepitant Impurity 53 Aprepitant Impurity 53
Cetrorelix Impurity 21 Cetrorelix Impurity 21
Brivaracetam Impurity 43 Brivaracetam Impurity 43
NA NA
Peramivir Intermediate Impurity 37 Peramivir Intermediate Impurity 37
Peramivir Diastereomer Impurity 1 Peramivir Diastereomer Impurity 1
NA NA
Canagliflozin Impurities 999 Canagliflozin Impurities 999
1,4,8,11-tetraazacyclotetradecane sodium chelation 1,4,8,11-tetraazacyclotetradecane sodium chelation
NA NA
4-Methoxy-2,3,5-trimethylpyride-N-oxide 4-Methoxy-2,3,5-trimethylpyride-N-oxide 86604-80-0 C9H13NO2
1-BOC-4-(5-NITRO-2-PYRIDYL)PIPERAZINE 1-BOC-4-(5-NITRO-2-PYRIDYL)PIPERAZINE 193902-78-2 C14H20N4O4
(1R,3r,5S)-8-methyl-8-azabicyclo[3.2.1]octan-3-yl 2-phenylacetate (1R,3r,5S)-8-methyl-8-azabicyclo[3.2.1]octan-3-yl 2-phenylacetate
Relugolix Impurity 25 Relugolix Impurity 25
Lumateperone Impurity 5 Lumateperone Impurity 5
Sugammadex Sodium Impurity ORG139131-1 Sugammadex Sodium Impurity ORG139131-1
2-[4-(Azidomethyl)phenyl]benzoic acid 2-[4-(Azidomethyl)phenyl]benzoic acid
2-[(2-AZIDOETHOXY)METHYL]-4-(2-CHLOROPHENYL)-3-ETHOXYCARBONYL-5-METHOXYCARBONYL)-6-METHYL-1,4-DIHYDROPYRIDINE 2-[(2-AZIDOETHOXY)METHYL]-4-(2-CHLOROPHENYL)-3-ETHOXYCARBONYL-5-METHOXYCARBONYL)-6-METHYL-1,4-DIHYDROPYRIDINE 88150-46-3 C20H23ClN4O5
((6aR,9R,10aR)-7-methyl-4,6,6a,7,8,9,10,10a-octahydroindolo[4,3-fg]quinolin-9-yl)methanol acetic acid salt ((6aR,9R,10aR)-7-methyl-4,6,6a,7,8,9,10,10a-octahydroindolo[4,3-fg]quinolin-9-yl)methanol acetic acid salt
4-nitro-1H-Imidazole-2-carboxaldehyde 4-nitro-1H-Imidazole-2-carboxaldehyde 33543-81-6 C4H3N3O3
1-CHLOROMETHYL-2,3,4-TRIMETHOXYBENZENE 1-CHLOROMETHYL-2,3,4-TRIMETHOXYBENZENE 1133-49-9 C10H13ClO3
Bumetanide Impurity 19 Bumetanide Impurity 19
Rocuronium Bromide Impurity 26 、27 Rocuronium Bromide Impurity 26 、27
Roxadustat Impurity 20 Roxadustat Impurity 20
Ruxolitinib Impurity Ruxolitinib Impurity
	Sitagliptin Impurity 82 Sitagliptin Impurity 82
(1S,7S,8S,8aR)-8-(2-((2R,4R)-4-hydroxy-6-oxotetrahydro-2H-pyran- 2-yl)ethyl)-3,7-dimethyl-1,2,4a,5,6,7,8,8a-octahydronaphthalen-1-yl 2,2-dimethylbutanoate (1S,7S,8S,8aR)-8-(2-((2R,4R)-4-hydroxy-6-oxotetrahydro-2H-pyran- 2-yl)ethyl)-3,7-dimethyl-1,2,4a,5,6,7,8,8a-octahydronaphthalen-1-yl 2,2-dimethylbutanoate
Perospirone Impurity 21 Perospirone Impurity 21
Perospirone Impurity 11 Perospirone Impurity 11
Dolutegravir Impurity 21 Dolutegravir Impurity 21
NA NA
Fondaparinux sodium impurity 7 Fondaparinux sodium impurity 7
Fondaparinux sodium impurity 3 Fondaparinux sodium impurity 3
Oxacillin sodium  Impurity B Oxacillin sodium Impurity B
Revefenacin Impurity 21 Revefenacin Impurity 21
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