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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
Alpha-D-Methylglucoside Alpha-D-Methylglucoside
4-Desacetyl Vincristine 4-Desacetyl Vincristine 3704-01-6 C44H54N4O9
	Relugolix Impurity 91 Relugolix Impurity 91
D,L N-Desmethylvenlafaxine D,L N-Desmethylvenlafaxine 149289-30-5 C16H25NO2
Tegoprazan Impurity 4 Tegoprazan Impurity 4
PIVALOYLOXYMETHYL 6-AMINOPENICILANATE PIVALOYLOXYMETHYL 6-AMINOPENICILANATE 25031-08-7 C14H22N2O5S
Bumetanide Impurity 23 Bumetanide Impurity 23
Rocuronium Bromide Impurity 34、35、36 Rocuronium Bromide Impurity 34、35、36
Vinpocetine impurity C Vinpocetine impurity C 70155-05-4 C23H28N2O3
Cloxacillin Impurity X Cloxacillin Impurity X
Benzamide, 4-[7-[6-cyano-5-(trifluoromethyl)-3-pyridinyl]-6,8-dithioxo-5,7-diazaspiro[3.4]oct-5-yl]-2-fluoro-N-methyl- Benzamide, 4-[7-[6-cyano-5-(trifluoromethyl)-3-pyridinyl]-6,8-dithioxo-5,7-diazaspiro[3.4]oct-5-yl]-2-fluoro-N-methyl- 2649802-40-2 C21H15F4N5OS2
Benzamide, 4-[7-[6-cyano-5-(trifluoromethyl)-3-pyridinyl]-6,8-dithioxo-5,7-diazaspiro[3.4]oct-5-yl]-2-fluoro-N-methyl- Benzamide, 4-[7-[6-cyano-5-(trifluoromethyl)-3-pyridinyl]-6,8-dithioxo-5,7-diazaspiro[3.4]oct-5-yl]-2-fluoro-N-methyl- 2649802-40-2 C21H15F4N5OS2
1-(4-((2-(4-hydroxypiperidin-1-yl)ethyl)(methyl)carbamoyl)benzyl)piperidine-4-carboxamide 1-(4-((2-(4-hydroxypiperidin-1-yl)ethyl)(methyl)carbamoyl)benzyl)piperidine-4-carboxamide
Azilsartan Impurity 107 Azilsartan Impurity 107
Perospirone Impurity 25 Perospirone Impurity 25
Paxlovid Impurity 16 Paxlovid Impurity 16
3-(2-(cyclopent-1-en-1-yl)-2-hydroxy-2-phenylacetoxy)-1,1-dimethylpyrrolidin-1-ium bromide 3-(2-(cyclopent-1-en-1-yl)-2-hydroxy-2-phenylacetoxy)-1,1-dimethylpyrrolidin-1-ium bromide
	Fondaparinux sodium impurity 17 Fondaparinux sodium impurity 17
(R)-8-(3-aminopiperidin-1-yl)-3-methyl-1,7-bis((4-methylquinazolin-2-yl)methyl)-3,7-dihydro-1H-purine-2,6-dione (R)-8-(3-aminopiperidin-1-yl)-3-methyl-1,7-bis((4-methylquinazolin-2-yl)methyl)-3,7-dihydro-1H-purine-2,6-dione
Oxytocin Impurity 8 Trifluoroacetate Oxytocin Impurity 8 Trifluoroacetate
Peramivir Dehydrated Impurity Peramivir Dehydrated Impurity
Apixaban Impurity 78 Apixaban Impurity 78
Formoterol Impurity 32 Formoterol Impurity 32
(1S,2S,3R,4R)-2-((R)-1-acetamido-2-ethylbutyl)-4-guanidino-3-hydroxycyclopentane-1-carboxylic acid (1S,2S,3R,4R)-2-((R)-1-acetamido-2-ethylbutyl)-4-guanidino-3-hydroxycyclopentane-1-carboxylic acid
Desloratadine EP impurity A hcl Desloratadine EP impurity A hcl 2250242-44-3 C19H21Cl2FN2
(R)-6-(2-((1S,2S)-2,6-dimethyl-1,2,3,4-tetrahydronaphthalen-1-yl) ethyl)-5,6-dihydro-2H-pyran-2-one and (R)-6-(2-((R)-2,6-dimethyl- 5,6,7,8-tetrahydronaphthalen-1-yl)ethyl)-5,6-dihydro-2H-pyran-2-one (R)-6-(2-((1S,2S)-2,6-dimethyl-1,2,3,4-tetrahydronaphthalen-1-yl) ethyl)-5,6-dihydro-2H-pyran-2-one and (R)-6-(2-((R)-2,6-dimethyl- 5,6,7,8-tetrahydronaphthalen-1-yl)ethyl)-5,6-dihydro-2H-pyran-2-one
(3S,4S)-Tofacitinib (3S,4S)-Tofacitinib 1092578-47-6 C16H20N6O
Rosuvastatin Impurity 145 Rosuvastatin Impurity 145
Apixaban Impurities 15 Complete Set Apixaban Impurities 15 Complete Set
Peramivir Intermediate impurity 1 Peramivir Intermediate impurity 1
Rosuvastatin EP Impurity G Rosuvastatin EP Impurity G
Peramivir Intermediate Impurity 43 Peramivir Intermediate Impurity 43
Peramivir Deacetylated Impurity Peramivir Deacetylated Impurity
Linagliptin Impurity 49 Linagliptin Impurity 49
Bimatoprost Impurity 23 Bimatoprost Impurity 23
Oxacillin Impurity IMPA Oxacillin Impurity IMPA
Rebamipide Impurity X(Rebamipide Impurity 7) Rebamipide Impurity X(Rebamipide Impurity 7)
(1S,2S,3R,5S)-3-(7-(((1R,2S)-2-(3-fluorophenyl)cyclopropyl)amino)-5-(propylthio)-3H-[1,2,3]triazolo[4,5-d]pyrimidin-3-yl)-5-(2-hydroxyethoxy)cyclopentane-1,2-diol (1S,2S,3R,5S)-3-(7-(((1R,2S)-2-(3-fluorophenyl)cyclopropyl)amino)-5-(propylthio)-3H-[1,2,3]triazolo[4,5-d]pyrimidin-3-yl)-5-(2-hydroxyethoxy)cyclopentane-1,2-diol
sodium 1-(5-hydroxy-3-methyl-1-phenyl-1H-pyrazol-4-yl)ethane-1-sulfonate sodium 1-(5-hydroxy-3-methyl-1-phenyl-1H-pyrazol-4-yl)ethane-1-sulfonate
Pyrimidine, 4,6-dichloro-5-nitroso-2-(propylthio)- Pyrimidine, 4,6-dichloro-5-nitroso-2-(propylthio)- 2512210-19-2 C7H7Cl2N3OS
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
Fondaparinux sodium impurity 12 Fondaparinux sodium impurity 12
Piperacillin impurity L Piperacillin impurity L
Piperacillin  Impurity X Piperacillin Impurity X
ETHYLTRITYLETHER ETHYLTRITYLETHER 968-39-8 C21H20O
Bosutinib Impurity 41 Bosutinib Impurity 41
(S)-3-Dimethylamino-3-phenylpropanol (S)-3-Dimethylamino-3-phenylpropanol 82769-75-3 C11H17NO
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
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
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
(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
Loxoprofen Sodium Impurity 35 Loxoprofen Sodium Impurity 35
Dashatinib impurity 46 Dashatinib impurity 46
(R,S)-N-Acetyl-3,4-dimethoxy phenylalanine (R,S)-N-Acetyl-3,4-dimethoxy phenylalanine 27313-65-1 C13H17NO5
Oxytocin oxide impurity reference substance Oxytocin oxide impurity reference substance
Troxipide Impurity 7 Troxipide Impurity 7
Avatrombopag Impurity 44 Avatrombopag Impurity 44
Bendamustine Impurity 37A Bendamustine Impurity 37A
Brivaracetam Impurity 50 Brivaracetam Impurity 50
6-Hydroxymoxifloxacin Impurities 6-Hydroxymoxifloxacin Impurities
(S)-4-(((R)-1-carboxy-2-((3-hydroxypropyl)thio)ethyl)amino)-3-hydroxy-4-oxobutanoic acid (S)-4-(((R)-1-carboxy-2-((3-hydroxypropyl)thio)ethyl)amino)-3-hydroxy-4-oxobutanoic acid
1,3-bis(5-bromo-2-methoxyphenyl)adamantane 1,3-bis(5-bromo-2-methoxyphenyl)adamantane 932033-56-2 C24H26Br2O2
(S)-dimethyl 2-(4-(((2,4-diaminopteridin-6-yl)methyl)(methyl)amino)benzamido)pentanedioate (S)-dimethyl 2-(4-(((2,4-diaminopteridin-6-yl)methyl)(methyl)amino)benzamido)pentanedioate 67676-60-2 C22H27ClN8O5
1-Cyclohexene-1-carboxylic acid, 4-(acetylamino)-3-(1-ethylpropoxy)-5-[[[5-(hydroxymethyl)-2-furanyl]methylene]amino]-, ethyl ester, (3S,4R,5S)- 1-Cyclohexene-1-carboxylic acid, 4-(acetylamino)-3-(1-ethylpropoxy)-5-[[[5-(hydroxymethyl)-2-furanyl]methylene]amino]-, ethyl ester, (3S,4R,5S)- 2413185-90-5 C22H32N2O6
2-Pyrazinecarboxylic acid, 6-methyl-, 4-oxide 2-Pyrazinecarboxylic acid, 6-methyl-, 4-oxide 51037-31-1 C6H6N2O3
tert-butyl (3R,5R)-7-(1-((3R,5R)-7-(tert-butoxy)-3,5-dihydroxy-7-oxoheptyl)-5-(4-fluorophenyl)-2-isopropyl-4-phenyl-1H-pyrrole-3-carboxamido)-3,5-dihydroxyheptanoate tert-butyl (3R,5R)-7-(1-((3R,5R)-7-(tert-butoxy)-3,5-dihydroxy-7-oxoheptyl)-5-(4-fluorophenyl)-2-isopropyl-4-phenyl-1H-pyrrole-3-carboxamido)-3,5-dihydroxyheptanoate
Furoxine GSK Open Ring Impurity Furoxine GSK Open Ring Impurity
INDEX NAME NOT YET ASSIGNED INDEX NAME NOT YET ASSIGNED 2681355-40-6 C29H34Cl2N6O4S2
Isavuconazole Impurity 48 Isavuconazole Impurity 48
5,5'-((1R,1'R)-((5,6-diethyl-2,3-dihydro-1H-inden-2-yl)azanediyl)bis(1-hydroxyethane-2,1-diyl))bis(8-hydroxyquinolin-2(1H)-one) 5,5'-((1R,1'R)-((5,6-diethyl-2,3-dihydro-1H-inden-2-yl)azanediyl)bis(1-hydroxyethane-2,1-diyl))bis(8-hydroxyquinolin-2(1H)-one)
(S)-2-(1-(3-ethoxy-4-methoxyphenyl)-2-(methylsulfonyl)ethyl)-5-nitroisoindoline-1,3-dione (S)-2-(1-(3-ethoxy-4-methoxyphenyl)-2-(methylsulfonyl)ethyl)-5-nitroisoindoline-1,3-dione C20H20N2O8S
2-(4-(2-(4-(1-(2-methoxyethyl)-1H-benzo[d]imidazol-2-yl)piperidin-1-yl)ethyl)phenyl)-2-methylpropanoic acid 2-(4-(2-(4-(1-(2-methoxyethyl)-1H-benzo[d]imidazol-2-yl)piperidin-1-yl)ethyl)phenyl)-2-methylpropanoic acid C27H35N3O3
Tafluprost Impurity 19 Tafluprost Impurity 19
Rosuvastatin Impurity 162 Rosuvastatin Impurity 162
Rosuvastatin Impurity 151 Rosuvastatin Impurity 151
Rosuvastatin Impurity 148 Rosuvastatin Impurity 148
FUROSEMIDE ACYL-B-D-GLUCURONIDE FUROSEMIDE ACYL-B-D-GLUCURONIDE 72967-59-0 C18H19ClN2O11S
Digoxin Impurity 1 Digoxin Impurity 1
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