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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
2-yl)oxy)-6,8,11-trihydroxy-8-(((2S,3S,4S,6R)-3-hydroxy-2-methyl-6-(((1S,3S)-3,5,12-trihydroxy-3-(2-hydroxyacetyl)-10-methoxy-6,11-dioxo-1,2,3,4,6,11- 2-yl)oxy)-6,8,11-trihydroxy-8-(((2S,3S,4S,6R)-3-hydroxy-2-methyl-6-(((1S,3S)-3,5,12-trihydroxy-3-(2-hydroxyacetyl)-10-methoxy-6,11-dioxo-1,2,3,4,6,11-
Peramivir Impurity 70 Peramivir Impurity 70
PANTOPRAZOLE SULFONE N-OXIDE PANTOPRAZOLE SULFONE N-OXIDE 953787-55-8 C16H15F2N3O6S
(R)-5-(aminomethyl)-2-((R)-carboxy((Z)-2-(furan-2-yl)-2-(methoxyimino)acetamido)methyl)-3,6-dihydro-2H-1,3-thiazine-4-carboxylic acid (R)-5-(aminomethyl)-2-((R)-carboxy((Z)-2-(furan-2-yl)-2-(methoxyimino)acetamido)methyl)-3,6-dihydro-2H-1,3-thiazine-4-carboxylic acid
Isavuconazole Impurity 44 Isavuconazole Impurity 44
Cobinic acid-abdeg-pentamide, Co-(cyano-κC)-, dihydrogen phosphate (ester), inner salt, 3'-ester with (5,6-dimethyl-1-α-D-ribofuranosyl-1H-benzimidazole-κN3) (9CI) Cobinic acid-abdeg-pentamide, Co-(cyano-κC)-, dihydrogen phosphate (ester), inner salt, 3'-ester with (5,6-dimethyl-1-α-D-ribofuranosyl-1H-benzimidazole-κN3) (9CI) 38437-93-3 C63H87CoN13O15P
Avatrombopag Impurity 75 Avatrombopag Impurity 75
Atorvastatin Impurity N(Calcium salt Atorvastatin Impurity N(Calcium salt
Rosuvastatin Impurity 164 Rosuvastatin Impurity 164
Rosuvastatin Impurity 123 Rosuvastatin Impurity 123
Relugolix Impurity 20 Relugolix Impurity 20
Amoxicillin EP Impurity Q Amoxicillin EP Impurity Q
7-PACE Impurity 2 7-PACE Impurity 2
5-(1-Methyl-4-Piperidyl)5H-Dibenzo 5-(1-Methyl-4-Piperidyl)5H-Dibenzo 3967-32-6 C21H23NO
Ertapenem Impurity I(USP) Ertapenem Impurity I(USP)
Acetonitrile, (3,4-dihydro-7-methoxy-1(2H)-naphthalenylidene)-, (Z)- (9CI) Acetonitrile, (3,4-dihydro-7-methoxy-1(2H)-naphthalenylidene)-, (Z)- (9CI) 178676-66-9 C13H13NO
Aflatoxin Aflatoxin 1402-68-2 C17H14O6.C17H14O7.C17H12O6.C17H12O7
Penicillin EP  Impurity A Penicillin EP Impurity A
4-Thia-1-azabicyclo[3.2.0]hept-2-ene-2-carboxylic acid, 6-(1-hydroxyethyl)-7-oxo-3-(tetrahydro-2-furanyl)-, [5R-[3(S*),5α,6α(R*)]]- (9CI) 4-Thia-1-azabicyclo[3.2.0]hept-2-ene-2-carboxylic acid, 6-(1-hydroxyethyl)-7-oxo-3-(tetrahydro-2-furanyl)-, [5R-[3(S*),5α,6α(R*)]]- (9CI) 106560-13-8 C12H15NO5S
1-Naphthalenecarboxylic acid, 8-[[(3S)-1-azabicyclo[2.2.2]oct-3-ylamino]methyl]-5,6,7,8-tetrahydro-, (8S)- 1-Naphthalenecarboxylic acid, 8-[[(3S)-1-azabicyclo[2.2.2]oct-3-ylamino]methyl]-5,6,7,8-tetrahydro-, (8S)- 2407763-21-5 C19H26N2O2
Peramivir Impurity 58 Peramivir Impurity 58
1-Naphthalenamine, 4-(2,3-dichlorophenyl)-1,2,3,4-tetrahydro-N-methyl-, (1R,4R)-rel- 1-Naphthalenamine, 4-(2,3-dichlorophenyl)-1,2,3,4-tetrahydro-N-methyl-, (1R,4R)-rel- 2124277-87-6 C17H17Cl2N
Voriconazole toxic impurity 2 Voriconazole toxic impurity 2
Avatrombopag Impurity 31 Avatrombopag Impurity 31
Cisatracurium besylate impurity19 Cisatracurium besylate impurity19 96946-52-0 C59H77N2O15S+
alpha-[4-[2-(dimethylamino)ethoxy]phenyl]-beta-ethyl-alpha-phenylphenethyl alcohol alpha-[4-[2-(dimethylamino)ethoxy]phenyl]-beta-ethyl-alpha-phenylphenethyl alcohol 748-97-0 C26H31NO2
Brivaracetam Impurity 53 Brivaracetam Impurity 53
ethyl hydrogen [R-(R*,R*)]-tartrate ethyl hydrogen [R-(R*,R*)]-tartrate 608-89-9 C6H10O6
ethyl 2,2,4-trichloro-3-oxobutyrate ethyl 2,2,4-trichloro-3-oxobutyrate 85153-67-9 C6H7Cl3O3
Neodigoxin Neodigoxin 55576-67-5 C41H64O14
(S)-6-((R)-2-amino-2-phenylacetamido)-2,2-dimethyl-7-oxo-2,3,4,7-tetrahydro-1,4-thiazepine-3-carboxylic acid (S)-6-((R)-2-amino-2-phenylacetamido)-2,2-dimethyl-7-oxo-2,3,4,7-tetrahydro-1,4-thiazepine-3-carboxylic acid
(R,R)-Palonosetron N-Oxide (R,R)-Palonosetron N-Oxide C19H24N2O2
[R(R*,R*]-2-amino-1-[p-(methylsulphonyl)phenyl]propane-1,3-diol [R(R*,R*]-2-amino-1-[p-(methylsulphonyl)phenyl]propane-1,3-diol 51458-28-7 C10H15NO4S
16alpha,17,21-trihydroxypregna-1,4,9(11)-triene-3,20-dione 21-acetate 16alpha,17,21-trihydroxypregna-1,4,9(11)-triene-3,20-dione 21-acetate 77017-20-0 C23H28O6
Pyrimidine, 4-chloro-5-nitro-2-(propylthio)- Pyrimidine, 4-chloro-5-nitro-2-(propylthio)- 2518331-26-3 C7H8ClN3O2S
Oseltamivir Impurity 110 Oseltamivir Impurity 110
Oseltamivir Impurity 108 Oseltamivir Impurity 108
Oseltamivir Impurity 102 Oseltamivir Impurity 102
1H-Pyrazole-1-propanenitrile, 4-(6-amino-5-formyl-4-pyrimidinyl)-β-cyclopentyl-, (βR)- 1H-Pyrazole-1-propanenitrile, 4-(6-amino-5-formyl-4-pyrimidinyl)-β-cyclopentyl-, (βR)- 2606144-45-8 C16H18N6O
4-Piperidinecarboxylic acid, 1-(4-pyridinylcarbonyl)-, ethyl ester 4-Piperidinecarboxylic acid, 1-(4-pyridinylcarbonyl)-, ethyl ester 252263-38-0 C14H18N2O3
(S)-6-(2-(2-(4-fluorophenyl)-5-isopropyl-3-phenyl-1H-pyrrol-1-yl) ethyl)-5,6-dihydro-2H-pyran-2-one (S)-6-(2-(2-(4-fluorophenyl)-5-isopropyl-3-phenyl-1H-pyrrol-1-yl) ethyl)-5,6-dihydro-2H-pyran-2-one
1,4-bis(4-nitrophenyl)piperazine 1,4-bis(4-nitrophenyl)piperazine 16264-05-4 C16H16N4O4
di(2,4-xylyl) disulphide di(2,4-xylyl) disulphide 13616-83-6 C16H18S2
Voriconzolegenotoxicimpurity Voriconzolegenotoxicimpurity
N4,N7-bis(3-chloro-4-fluorophenyl)-8-nitroquinazoline-4,7-diamine N4,N7-bis(3-chloro-4-fluorophenyl)-8-nitroquinazoline-4,7-diamine
1H-Benzimidazole-2-butanoic acid, 5-[(2-hydroxyethyl)amino]-1-methyl- 1H-Benzimidazole-2-butanoic acid, 5-[(2-hydroxyethyl)amino]-1-methyl- 956344-27-7 C14H19N3O3
Iohexol ImpuritiesD Iohexol ImpuritiesD
ethyl (Z)-3-(4-((1H-imidazol-1-yl)methyl)phenyl)acrylate ethyl (Z)-3-(4-((1H-imidazol-1-yl)methyl)phenyl)acrylate
2-Demethoxy-2-chloro Urapidil HCl 2-Demethoxy-2-chloro Urapidil HCl
Isavuconazole Impurity 43 Isavuconazole Impurity 43
Elagolix Impurity 41 Elagolix Impurity 41
Ethyl (2E)-3-[4-(Dibromomethyl)phenyl]prop-2-enoate Ethyl (2E)-3-[4-(Dibromomethyl)phenyl]prop-2-enoate
8-chloro-11-(1-((5-methylpyridin-3-yl)methyl)-1,2,3,6-tetrahydropyridin-4-yl)-6,11-dihydro-5H-benzo[5,6]cyclohepta[1,2-b]pyridine 8-chloro-11-(1-((5-methylpyridin-3-yl)methyl)-1,2,3,6-tetrahydropyridin-4-yl)-6,11-dihydro-5H-benzo[5,6]cyclohepta[1,2-b]pyridine
	Bumetanide Impurity 18 Bumetanide Impurity 18
Bumetanide Impurity 3 Bumetanide Impurity 3
Cefoxitin EP Impurity F (S-methoxy cefoxitin) Cefoxitin EP Impurity F (S-methoxy cefoxitin)
((((3R,6S)-6-carbamoylpiperidin-3-yl)(ethoxycarbonyl)amino)oxy)sulfonic acid ((((3R,6S)-6-carbamoylpiperidin-3-yl)(ethoxycarbonyl)amino)oxy)sulfonic acid
INDEX NAME NOT YET ASSIGNED INDEX NAME NOT YET ASSIGNED 2514949-81-4 C20H28N4O2
3-acetamidophthalic acid 3-acetamidophthalic acid 15371-06-9 C10H9NO5
Dexamethasone EP Impurity E Dexamethasone EP Impurity E 13209-41-1 C22H28O4
6-amino-5-formamido-1,3-dimethyluracil 6-amino-5-formamido-1,3-dimethyluracil 7597-60-6 C7H10N4O3
3-((3R,4R)-4-methyl-3-(methyl(7H-pyrrolo[2,3-d]pyrimidin-2-yl)amino)piperidin-1-yl)-3-oxopropanenitrile 3-((3R,4R)-4-methyl-3-(methyl(7H-pyrrolo[2,3-d]pyrimidin-2-yl)amino)piperidin-1-yl)-3-oxopropanenitrile 2374700-40-8 C16H20N6O
7H-Pyrido[1,2,3-de]-1,4-benzoxazine-6-carboxylic acid, 9-fluoro-2,3-dihydro-2-methyl-10-(4-methyl-1-piperazinyl)-7-oxo-, (S)- (9CI) 7H-Pyrido[1,2,3-de]-1,4-benzoxazine-6-carboxylic acid, 9-fluoro-2,3-dihydro-2-methyl-10-(4-methyl-1-piperazinyl)-7-oxo-, (S)- (9CI) 129815-82-3 C18H20FN3O4
Piperazine, 1-[2-[(4-methoxyphenyl)methyl]-4-methylphenyl]- Piperazine, 1-[2-[(4-methoxyphenyl)methyl]-4-methylphenyl]- 769083-63-8 C19H24N2O
1,3-diisopropylurea 1,3-diisopropylurea 4128-37-4 C7H16N2O
Benzoic acid, 4-[7-[6-cyano-5-(trifluoromethyl)-3-pyridinyl]-8-oxo-6-thioxo-5,7-diazaspiro[3.4]oct-5-yl]-2-fluoro-, methyl ester Benzoic acid, 4-[7-[6-cyano-5-(trifluoromethyl)-3-pyridinyl]-8-oxo-6-thioxo-5,7-diazaspiro[3.4]oct-5-yl]-2-fluoro-, methyl ester 1950587-19-5 C21H14F4N4O3S
Acetic acid, 2-[(5-bromo-2-pyridinyl)amino]-2-oxo-, ethyl ester Acetic acid, 2-[(5-bromo-2-pyridinyl)amino]-2-oxo-, ethyl ester 141354-54-3 C9H9BrN2O3
Peramivir diacetyl impurity 1 Peramivir diacetyl impurity 1
Urapidil Impurity 17 Urapidil Impurity 17
Clindamycin Impurity 86 Clindamycin Impurity 86
Canagliflozin Impurity 77 Canagliflozin Impurity 77
Carbazochrome Sodium Sulfonate Impurity I Carbazochrome Sodium Sulfonate Impurity I
Tadalafil impurities 45 Tadalafil impurities 45
Posaconazole Impurities 10 Complete Set Posaconazole Impurities 10 Complete Set
Cetrorelix Impurity 18 Cetrorelix Impurity 18
Cetrorelix Impurity 13 Cetrorelix Impurity 13
Bortezomib Impurity G Full Set Pre- Bortezomib Impurity G Full Set Pre-
Cetrorelix Impurity 2 (+L-Ser) Cetrorelix Impurity 2 (+L-Ser)
Peramivir Intermediate Impurity 39 Peramivir Intermediate Impurity 39
Peramivir Intermediate Impurity 59 Peramivir Intermediate Impurity 59
Criborole impurity 999 Criborole impurity 999
Atracurium impurity O drops Atracurium impurity O drops
Pemetrexed Disodium Impurity 21-30 Pemetrexed Disodium Impurity 21-30
Bimatoprost Impurity 2 Bimatoprost Impurity 2
Guanosine Guanosine 30747-23-0 C18H21N5O9
Oseltamivir Impurity 126 Oseltamivir Impurity 126
2H-1,4-Benzoxazin-3(4H)-one, 6-hydroxy-8-[(1R)-1-hydroxy-2-[[2-(4-hydroxyphenyl)-1,1-dimethylethyl]amino]ethyl]-, hydrochloride (1:1) 2H-1,4-Benzoxazin-3(4H)-one, 6-hydroxy-8-[(1R)-1-hydroxy-2-[[2-(4-hydroxyphenyl)-1,1-dimethylethyl]amino]ethyl]-, hydrochloride (1:1) 936490-85-6 C20H25ClN2O5
Desacetylvinblastine hydrazide Desacetylvinblastine hydrazide 55383-37-4 C43H56N6O7
4-hydroxypyrrolidin-2-one 4-hydroxypyrrolidin-2-one 96820-00-7 C4H7NO2
4'-hydroxyflurbiprofen 4'-hydroxyflurbiprofen 52807-12-2 C15H13FO3
D-biotin-d-sulfoxide D-biotin-d-sulfoxide 10406-89-0 C10H16N2O4S
3,4-dihydroxyphenylpyruvic acid 3,4-dihydroxyphenylpyruvic acid 4228-66-4 C9H8O5
Imimidistine impurity E Imimidistine impurity E
delta(3)-cefotiam delta(3)-cefotiam 142182-63-6 C18H23N9O4S3
anemonin anemonin 508-44-1 C10H8O4
alpha-(chloromethyl)-2-hydroxymethyl-5-nitroimidazole-1-ethanol alpha-(chloromethyl)-2-hydroxymethyl-5-nitroimidazole-1-ethanol 62580-79-4 C7H10ClN3O4
7-(deoxyadenosin-N(6)-yl)aristolactam I 7-(deoxyadenosin-N(6)-yl)aristolactam I 127191-86-0 C27H22N6O7
4-hydroxypenicillin V 4-hydroxypenicillin V 20880-67-5 C16H18N2O6S
BENAZEPRILAT BENAZEPRILAT 86541-78-8 C22H24N2O5
9-Methylene-9H-fluorene 9-Methylene-9H-fluorene 4425-82-5 C14H10
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