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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
N-DESMETHYLCLOZAPINE N-DESMETHYLCLOZAPINE 6104-71-8 C17H17ClN4
PENTACHLOROANISOLE PENTACHLOROANISOLE 1825-21-4 C7H3Cl5O
BROMOPRIDE BROMOPRIDE 4093-35-0 C14H22BrN3O2
3,4,5-TRICHLOROPHENOL 3,4,5-TRICHLOROPHENOL 609-19-8 C6H3Cl3O
MEPENZOLATE BROMIDE MEPENZOLATE BROMIDE 76-90-4 C21H26BrNO3
Terbacil Terbacil 5902-51-2 C9H13ClN2O2
Soybean Flour Soybean Flour 68513-95-1
2,3,4,5-TETRACHLOROPHENOL 2,3,4,5-TETRACHLOROPHENOL 4901-51-3 C6H2Cl4O
Tris(2,3-dibromopropyl)phosphate Tris(2,3-dibromopropyl)phosphate 126-72-7 C9H15Br6O4P
Chlordecone Chlordecone 143-50-0 C10Cl10O
4-CARBOXY-2,2,6,6-TETRAMETHYLPIPERIDINE 1-OXYL 4-CARBOXY-2,2,6,6-TETRAMETHYLPIPERIDINE 1-OXYL 37149-18-1 C10H18NO3*
6-METHYLCHRYSENE 6-METHYLCHRYSENE 1705-85-7 C19H14
METHYSTICIN METHYSTICIN 495-85-2 C15H14O5
2,4,5-TRICHLOROTOLUENE 2,4,5-TRICHLOROTOLUENE 6639-30-1 C7H5Cl3
2,4,6-TRI-TERT-BUTYLNITROSOBENZENE 2,4,6-TRI-TERT-BUTYLNITROSOBENZENE 24973-59-9 C18H29NO
2,4-DIAMINO-6-DIMETHYLAMINO-1,3,5-TRIAZINE 2,4-DIAMINO-6-DIMETHYLAMINO-1,3,5-TRIAZINE 1985-46-2 C5H10N6
NEOERIOCITRIN NEOERIOCITRIN 13241-32-2 C27H32O15
QUINMERAC QUINMERAC 90717-03-6 C11H8ClNO2
1-Cyanocyclohexaneacetic acid 1-Cyanocyclohexaneacetic acid 133481-09-1 C9H13NO2
Triflumizole Triflumizole 99387-89-0 C15H15ClF3N3O
NEBURON NEBURON 555-37-3 C12H16Cl2N2O
2,4-DB METHYL ESTER 2,4-DB METHYL ESTER 18625-12-2 C11H12Cl2O3
CAPTOPRIL DISULFIDE CAPTOPRIL DISULFIDE 64806-05-9 C18H28N2O6S2
1-PHENYLPENTADECANE 1-PHENYLPENTADECANE 2131-18-2 C21H36
2-(Ethylamino)propiophenone hydrochloride 2-(Ethylamino)propiophenone hydrochloride 51553-17-4 C11H16ClNO
IOXYNIL OCTANOATE IOXYNIL OCTANOATE 3861-47-0 C15H17I2NO2
2-BENZYL-1,2,3,6,7,11B-HEXAHYDRO-4H-PYRAZION[2,1-A] ISOQUINOLINE-4-ONE 2-BENZYL-1,2,3,6,7,11B-HEXAHYDRO-4H-PYRAZION[2,1-A] ISOQUINOLINE-4-ONE 54761-87-4 C19H18N2O2
TETRACONAZOLE TETRACONAZOLE 112281-77-3 C13H11Cl2F4N3O
PENTACHLOROTHIOANISOLE PENTACHLOROTHIOANISOLE 1825-19-0 C7H3Cl5S
CHLORFENAC CHLORFENAC 85-34-7 C8H5Cl3O2
M-CYMENE M-CYMENE 535-77-3 C10H14
MICROCYSTIN-LR MICROCYSTIN-LR 101043-37-2 C49H74N10O12
FLONICAMID FLONICAMID 158062-67-0 C9H6F3N3O
OXELADIN CITRATE OXELADIN CITRATE 52432-72-1 C20H33NO3.C6H8O7
2,4,6-TRIS(HEPTAFLUOROPROPYL)-1,3,5-TRIAZINE 2,4,6-TRIS(HEPTAFLUOROPROPYL)-1,3,5-TRIAZINE 915-76-4 C12F21N3
2-Diphenylmethylpiperidine hydrochloride 2-Diphenylmethylpiperidine hydrochloride 5807-81-8 C18H22ClN
(3aS-cis)-1,3-dibenzyltetrahydro-1H-thieno[3,4-d]imidazole-2,4-dione (3aS-cis)-1,3-dibenzyltetrahydro-1H-thieno[3,4-d]imidazole-2,4-dione 28092-52-6 C19H18N2O2S
L-Cefadroxil Impurity F(EP) L-Cefadroxil Impurity F(EP)
methyl L-prolinate methyl L-prolinate 2577-48-2 C6H11NO2
sodium (S,Z)-2-((1S,2R)-1-carboxylato-2-hydroxypropyl)-5-(4- hydroxybutylidene)-2,5-dihydrothiazole-4-carboxylate sodium (S,Z)-2-((1S,2R)-1-carboxylato-2-hydroxypropyl)-5-(4- hydroxybutylidene)-2,5-dihydrothiazole-4-carboxylate
3-(((3R)-3-((R)-1-(3,5-bis(trifluoromethyl)phenyl)ethoxy)-2-(4-fluorophenyl)-1,4-dioxan-2-ylamino)methyl)-1H-1,2,4-triazol-5(4H)-one 3-(((3R)-3-((R)-1-(3,5-bis(trifluoromethyl)phenyl)ethoxy)-2-(4-fluorophenyl)-1,4-dioxan-2-ylamino)methyl)-1H-1,2,4-triazol-5(4H)-one
2,4,6-tripropyl-1,3,5-trioxane 2,4,6-tripropyl-1,3,5-trioxane 2396-43-2 C12H24O3
Oseltamivir  Impurity 94 Oseltamivir Impurity 94
Oseltamivir  Impurity 82 Oseltamivir Impurity 82
Oseltamivir  Impurity 74 Oseltamivir Impurity 74
Uridine, 5'-(2-methylpropanoate) (9CI) Uridine, 5'-(2-methylpropanoate) (9CI) 886538-48-3 C13H18N2O7
Dapagliflozin Impurity 47 Dapagliflozin Impurity 47
Crisaborole Impurity 17 Crisaborole Impurity 17
Crisaborole Impurity 19 Crisaborole Impurity 19
1,5-Pentanedione, 1-(2-fluorophenyl)-5-[(4S)-2-oxo-4-phenyl-3-oxazolidinyl]- 1,5-Pentanedione, 1-(2-fluorophenyl)-5-[(4S)-2-oxo-4-phenyl-3-oxazolidinyl]- 2514695-40-8 C20H18FNO4
4-ethoxy-3-(4-pyridyl)-3-buten-2-one 4-ethoxy-3-(4-pyridyl)-3-buten-2-one 88349-61-5 C11H13NO2
Phosphonic acid, [[2-(6-amino-9H-purin-9-yl)propoxy]methyl]- (9CI) Phosphonic acid, [[2-(6-amino-9H-purin-9-yl)propoxy]methyl]- (9CI) 107021-20-5 C9H14N5O4P
Sitagliptin EP Impurity 7 Sitagliptin EP Impurity 7
Sitagliptin EP Impurity H Sitagliptin EP Impurity H
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)
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
1,3-dihydro-4-methyl-2H-1,5-benzodiazepin-2-one 1,3-dihydro-4-methyl-2H-1,5-benzodiazepin-2-one 6276-48-8 C10H10N2O
(E)-2-methoxy-4-(prop-1-enyl)phenol (E)-2-methoxy-4-(prop-1-enyl)phenol 5932-68-3 C10H12O2
3-amino-5-[(methylthio)methyl]oxazolidin-2-one 3-amino-5-[(methylthio)methyl]oxazolidin-2-one 25517-72-0 C5H10N2O2S
7-Benzofurancarboxamide, 4-amino-5-chloro-2,3-dihydro-3-hydroxy-N-[1-(3-methoxypropyl)-4-piperidinyl]- 7-Benzofurancarboxamide, 4-amino-5-chloro-2,3-dihydro-3-hydroxy-N-[1-(3-methoxypropyl)-4-piperidinyl]- 2636673-48-6 C18H26ClN3O4
Beprostatin impurity 4 Beprostatin impurity 4
cis-5-chloro-2,3,3a,12b-tetrahydro-2-methyl-1H-dibenz[2,3:6,7]oxepino[4,5-c]pyrrole cis-5-chloro-2,3,3a,12b-tetrahydro-2-methyl-1H-dibenz[2,3:6,7]oxepino[4,5-c]pyrrole 65621-78-5 C17H16ClNO
methyl tosylcarbamate methyl tosylcarbamate 14437-03-7 C9H11NO4S
(1R,2R,4S,5S,7s,9r)-9-butyl-9-methyl-7-((2-phenylacryloyl)oxy)-3-oxa-9-azatricyclo[3.3.1.02,4]nonan-9-ium (1R,2R,4S,5S,7s,9r)-9-butyl-9-methyl-7-((2-phenylacryloyl)oxy)-3-oxa-9-azatricyclo[3.3.1.02,4]nonan-9-ium 786598-71-8 C21H28NO3+
(+)-2-Ethoxy-4-(N-3-Methyl-1(S)-(2-(1-Piperidinyl)Phenyl)-Butyl)Carbamoylmethyl) (+)-2-Ethoxy-4-(N-3-Methyl-1(S)-(2-(1-Piperidinyl)Phenyl)-Butyl)Carbamoylmethyl) 147770-06-7 C29H40N2O4
4-Chloro-2-(chloromethyl)-3-Methyl Pyridine Hydrochloride 4-Chloro-2-(chloromethyl)-3-Methyl Pyridine Hydrochloride 152402-97-6 C7H8Cl3N
4-(3-CYANO-2-METHYLPROPIONYL)ACETAMILIDE 4-(3-CYANO-2-METHYLPROPIONYL)ACETAMILIDE 42075-21-8
Erythromycin, 6-O-Methyl-2',4'-Bis-O-(Trimethylsilyl)-, 9-[O-(1-Methoxy-1-Methylethyl)Oxime] Erythromycin, 6-O-Methyl-2',4'-Bis-O-(Trimethylsilyl)-, 9-[O-(1-Methoxy-1-Methylethyl)Oxime] 119699-81-9 C48H94N2O14Si2
(R)-8-(3-aminopiperidin-1-yl)-3-methyl-1-((4-methylquinazolin-2-yl)methyl)-7-(3-oxobutyl)-3,7-dihydro-1H-purine-2,6-dione (R)-8-(3-aminopiperidin-1-yl)-3-methyl-1-((4-methylquinazolin-2-yl)methyl)-7-(3-oxobutyl)-3,7-dihydro-1H-purine-2,6-dione
Isavuconazole Impurity 37 Isavuconazole Impurity 37
"mixture of 2-amino-9-[[2-(hydroxymethoxy) ethoxy]methyl]-1,9-dihydro-6H-purin-6-one and 2-amino-9-[[2-(hydroxyethoxy)methoxy]methyl]-1,9- dihydro-6H-purin-6-one,"
N-((R)-1-(((R)-3-methyl-1-((3aS,4S,6S,7aR)-3a,5,5-trimethylhexahydro-4,6-methanobenzo[d][1,3,2]dioxaborol-2-yl)butyl)amino)-1-oxo-3-phenylpropan-2-yl)pyrazine-2-carboxamide N-((R)-1-(((R)-3-methyl-1-((3aS,4S,6S,7aR)-3a,5,5-trimethylhexahydro-4,6-methanobenzo[d][1,3,2]dioxaborol-2-yl)butyl)amino)-1-oxo-3-phenylpropan-2-yl)pyrazine-2-carboxamide 1375004-39-9 C29H39BN4O4
(S)-1-(2-(((1r,3R,5S,7S)-3,5-dihydroxyadamantan-1-yl)amino)acetyl)pyrrolidine-2-carbonitrile (S)-1-(2-(((1r,3R,5S,7S)-3,5-dihydroxyadamantan-1-yl)amino)acetyl)pyrrolidine-2-carbonitrile
Mannitol EP impurity B Mannitol EP impurity B
Mannitol EP impurity A Mannitol EP impurity A
Peramivir Amino Carboxylic Isomerism Impurity Peramivir Amino Carboxylic Isomerism Impurity
Peramivir Chlorinated Impurity Peramivir Chlorinated Impurity
Brivaracetam Impurity 999 Brivaracetam Impurity 999
Dasatinib impurity 48 Dasatinib impurity 48
Pemetrexed Impurity 120 Pemetrexed Impurity 120
Ticagrelor Impurity 101 Ticagrelor Impurity 101
4-tosyl-1,4,8,11-tetraazabicyclo[9.3.1]pentadecane 4-tosyl-1,4,8,11-tetraazabicyclo[9.3.1]pentadecane
1-(3-((2,4-dimethylphenyl)thio)phenyl)piperazine hydrochloride 1-(3-((2,4-dimethylphenyl)thio)phenyl)piperazine hydrochloride 2137793-92-9
Apixaban impurity 66S Apixaban impurity 66S
Aatrombopag Impurity 17 Aatrombopag Impurity 17 1268118-96-2 C7H4BrClN2S2
(R)-(-)-2-AMINOBUTANAMIDE HYDROCHLORIDE, 97% (R)-(-)-2-AMINOBUTANAMIDE HYDROCHLORIDE, 97% 103765-03-3 C4H11ClN2O
Flomoxef Impurity 20 Sodium Salt Flomoxef Impurity 20 Sodium Salt 2095697-77-9 C15H18F2N6O7S2
(Z)-3-(4-((1H-imidazol-1-yl)methyl)phenyl)acrylic acid (Z)-3-(4-((1H-imidazol-1-yl)methyl)phenyl)acrylic acid 883903-90-0 C13H13N2NaO2
((2R,3S,4R)-3,4,5-trihydroxytetrahydrofuran-2-yl)methyl isobutyrate ((2R,3S,4R)-3,4,5-trihydroxytetrahydrofuran-2-yl)methyl isobutyrate 2591381-21-2 C9H16O6
3-Thiophenecarboxylic acid, 4-(bromomethyl)-2-[[(2,6-difluorophenyl)methyl](propoxycarbonyl)amino]-5-(4-nitrophenyl)-, ethyl ester 3-Thiophenecarboxylic acid, 4-(bromomethyl)-2-[[(2,6-difluorophenyl)methyl](propoxycarbonyl)amino]-5-(4-nitrophenyl)-, ethyl ester 2591260-07-8 C25H23BrF2N2O6S
Cyclohexanecarboxylic acid, 2-[[[4-[4-(1,2-benzisothiazol-3-yl)-1-piperazinyl]butyl]amino]carbonyl]-, (1R,2S)-rel- Cyclohexanecarboxylic acid, 2-[[[4-[4-(1,2-benzisothiazol-3-yl)-1-piperazinyl]butyl]amino]carbonyl]-, (1R,2S)-rel- 190582-37-7 C23H32N4O3S
Ivabradine Impurity II Ivabradine Impurity II
(1R,2R,4S,5S,7r)-9-methyl-3-oxa-9-azatricyclo[3.3.1.02,4]nonan-7-yl 2-hydroxy-2,2-di(thiophen-2-yl)acetate (1R,2R,4S,5S,7r)-9-methyl-3-oxa-9-azatricyclo[3.3.1.02,4]nonan-7-yl 2-hydroxy-2,2-di(thiophen-2-yl)acetate 792155-94-3 C18H19NO4S2
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