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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
ALDICARB-SULFONE ALDICARB-SULFONE 1646-88-4 C7H14N2O4S
DIHYDROERGOCRISTINE MESYLATE DIHYDROERGOCRISTINE MESYLATE 24730-10-7 C36H45N5O8S
AFLATOXIN M1 AFLATOXIN M1 6795-23-9 C17H12O7
EPN EPN 2104-64-5 C14H14NO4PS
Pyributicarb Pyributicarb 88678-67-5 C18H22N2O2S
N-DESMETHYLCLOZAPINE N-DESMETHYLCLOZAPINE 6104-71-8 C17H17ClN4
PENTACHLOROANISOLE PENTACHLOROANISOLE 1825-21-4 C7H3Cl5O
Soybean Flour Soybean Flour 68513-95-1
Terbacil Terbacil 5902-51-2 C9H13ClN2O2
2,3,4,5-TETRACHLOROPHENOL 2,3,4,5-TETRACHLOROPHENOL 4901-51-3 C6H2Cl4O
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
Tris(2,3-dibromopropyl)phosphate Tris(2,3-dibromopropyl)phosphate 126-72-7 C9H15Br6O4P
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
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
6-METHYLCHRYSENE 6-METHYLCHRYSENE 1705-85-7 C19H14
Chlordecone Chlordecone 143-50-0 C10Cl10O
METHYSTICIN METHYSTICIN 495-85-2 C15H14O5
QUINMERAC QUINMERAC 90717-03-6 C11H8ClNO2
4-CARBOXY-2,2,6,6-TETRAMETHYLPIPERIDINE 1-OXYL 4-CARBOXY-2,2,6,6-TETRAMETHYLPIPERIDINE 1-OXYL 37149-18-1 C10H18NO3*
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
Glycine, N-(2-aminobenzoyl)-, ethyl ester Glycine, N-(2-aminobenzoyl)-, ethyl ester 5973-34-2 C11H14N2O3
6-Chloro-3,4-dihydro-4-methyl-3-oxo-2H-1,4-benzoxanine-8-carboxylic acid 6-Chloro-3,4-dihydro-4-methyl-3-oxo-2H-1,4-benzoxanine-8-carboxylic acid 123040-79-9 C10H8ClNO4
3-Amino-3-azabicyclo[3.3.0]octane 3-Amino-3-azabicyclo[3.3.0]octane 54528-00-6 C7H14N2
(S)-Methyl 2-aminobutanoate (S)-Methyl 2-aminobutanoate 15399-22-1 C5H11NO2
(6S,8S,9S,10R,11S,13S,14S,17R)-17-(2,2-dihydroxyacetyl)-11,17-dihydroxy-6,10,13-trimethyl-6,7,8,9,10,11,12,13,14,15,16,17-dodecahydro-3H-cyclopenta[a]phenanthren-3-one (6S,8S,9S,10R,11S,13S,14S,17R)-17-(2,2-dihydroxyacetyl)-11,17-dihydroxy-6,10,13-trimethyl-6,7,8,9,10,11,12,13,14,15,16,17-dodecahydro-3H-cyclopenta[a]phenanthren-3-one
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)
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
Bimatoprost Impurity 11 Bimatoprost Impurity 11
Bimatoprost Impurity 9 Bimatoprost Impurity 9
Dolutegravir Impurity 18 Dolutegravir Impurity 18
PeraMpanel PeraMpanel 380918-53-6 C23H15N3O
Lenvatinib Impurity 33 Lenvatinib Impurity 33
isopropyl 2-(2-oxopyrrolidin-1-yl)acetate isopropyl 2-(2-oxopyrrolidin-1-yl)acetate 1249080-59-8 C9H15NO3
Pitavastatin Impurity 71 Pitavastatin Impurity 71
Rosuvastatin EP Impurity M Sodium Salt Rosuvastatin EP Impurity M Sodium Salt
Furosemide impurity 8 Furosemide impurity 8
Febuxostat Impurity 108 Febuxostat Impurity 108
Flucloxacillin EP Impurity J Flucloxacillin EP Impurity J
Phosphonic acid, P-[[(1R)-2-(6-amino-9H-purin-9-yl)-1-methylethoxy]methyl]-, mono[(1R)-2-(6-amino-9H-purin-9-yl)-1-methylethyl] ester Phosphonic acid, P-[[(1R)-2-(6-amino-9H-purin-9-yl)-1-methylethoxy]methyl]-, mono[(1R)-2-(6-amino-9H-purin-9-yl)-1-methylethyl] ester 1878175-77-9 C17H23N10O4P
Acetic acid, 2-[[(1S,2R,4S)-4-[(dimethylamino)carbonyl]-2-[[(4,5,6,7-tetrahydro-5-methylthiazolo[5,4-c]pyridin-2-yl)carbonyl]amino]cyclohexyl]amino]-2-oxo-, ethyl ester Acetic acid, 2-[[(1S,2R,4S)-4-[(dimethylamino)carbonyl]-2-[[(4,5,6,7-tetrahydro-5-methylthiazolo[5,4-c]pyridin-2-yl)carbonyl]amino]cyclohexyl]amino]-2-oxo-, ethyl ester 480450-85-9 C21H31N5O5S
3H-Oxireno[3,4]pyrrolo[2,1-b][1,3]oxazine-3-butanoic acid, 1b-(4-fluorophenyl)hexahydro-β,7-dihydroxy-7-(1-methylethyl)-1a-phenyl-7a-[(phenylamino)carbonyl]-, (βR,3R)- 3H-Oxireno[3,4]pyrrolo[2,1-b][1,3]oxazine-3-butanoic acid, 1b-(4-fluorophenyl)hexahydro-β,7-dihydroxy-7-(1-methylethyl)-1a-phenyl-7a-[(phenylamino)carbonyl]-, (βR,3R)- 1193817-52-5 C33H35FN2O7
Hexanoic acid, 3-formyl-, ethyl ester Hexanoic acid, 3-formyl-, ethyl ester 54374-02-6 C9H16O3
D-erythro-Hexonic acid, 2,4-dideoxy-3,5-O-(1-methylethylidene)- D-erythro-Hexonic acid, 2,4-dideoxy-3,5-O-(1-methylethylidene)- 154877-92-6 C9H16O5
INDEX NAME NOT YET ASSIGNED INDEX NAME NOT YET ASSIGNED 2463617-49-2 C51H56N16O4
Benzoic acid, 4-[(1,3-dihydro-1-hydroxy-2,1-benzoxaborol-5-yl)oxy]- Benzoic acid, 4-[(1,3-dihydro-1-hydroxy-2,1-benzoxaborol-5-yl)oxy]- 906673-43-6 C14H11BO5
Benzenemethanamine, α,α'-sulfonylbis(methylene)bis[3-ethoxy-4-methoxy- Benzenemethanamine, α,α'-sulfonylbis(methylene)bis[3-ethoxy-4-methoxy- 2417213-71-7 C22H32N2O6S
1H-Purine-2,6-dione, 8-(3-amino-1-piperidinyl)-7-(3-chloro-2-buten-1-yl)-3,7-dihydro-3-methyl-1-[(4-methyl-2-quinazolinyl)methyl]- 1H-Purine-2,6-dione, 8-(3-amino-1-piperidinyl)-7-(3-chloro-2-buten-1-yl)-3,7-dihydro-3-methyl-1-[(4-methyl-2-quinazolinyl)methyl]- 2138805-26-0 C25H29ClN8O2
1,3-Benzenedicarboxamide, 5-[acetyl(2,3-dihydroxypropyl)amino]-N1,N3-bis(2,3-dihydroxypropyl)-2,4-diiodo- 1,3-Benzenedicarboxamide, 5-[acetyl(2,3-dihydroxypropyl)amino]-N1,N3-bis(2,3-dihydroxypropyl)-2,4-diiodo- 1651211-78-7 C19H27I2N3O9
(2S,3R,4R,5S,6R)-2-(4-chloro-3-(4-ethoxy-3-ethylbenzyl)phenyl)-6-(hydroxymethyl)tetrahydro-2H-pyran-3,4,5-triol (2S,3R,4R,5S,6R)-2-(4-chloro-3-(4-ethoxy-3-ethylbenzyl)phenyl)-6-(hydroxymethyl)tetrahydro-2H-pyran-3,4,5-triol
(E)-1-(4-(2-carboxyvinyl)benzyl)-1H-imidazole 3-oxide (E)-1-(4-(2-carboxyvinyl)benzyl)-1H-imidazole 3-oxide
Aprepitant impurity 2 Aprepitant impurity 2
Aprepitant impurity 4 Aprepitant impurity 4
Vonoprazan Impurity B-2 Vonoprazan Impurity B-2
2-(Cyanomethylthio)acetic acid 2-(Cyanomethylthio)acetic acid 55817-29-3 C4H5NO2S
2(1H)-Pyridinone, 1-(3-aminophenyl)-5,6-dihydro-3-(4-morpholinyl)- 2(1H)-Pyridinone, 1-(3-aminophenyl)-5,6-dihydro-3-(4-morpholinyl)- 2437650-75-2 C15H19N3O2
4(1H)-Pyridinone, 1-(6-methoxy-1H-benzimidazol-2-yl)-2,3,5-trimethyl- 4(1H)-Pyridinone, 1-(6-methoxy-1H-benzimidazol-2-yl)-2,3,5-trimethyl- 2512216-37-2 C16H17N3O2
Budesonide Impurity 31 Budesonide Impurity 31
Budesonide Impurity 23 Budesonide Impurity 23
Hexanoic acid, 3-(chloromethyl)-, (3R)- Hexanoic acid, 3-(chloromethyl)-, (3R)- 2101641-90-9 C7H13ClO2
Bisoprolol Impurity Bisoprolol Impurity 2226263-68-7 C18H31NO4
2(1H)-Quinolinone, 5-[(1R)-1,2-dihydroxyethyl]-8-(phenylmethoxy)- 2(1H)-Quinolinone, 5-[(1R)-1,2-dihydroxyethyl]-8-(phenylmethoxy)- 1261219-83-3 C18H17NO4
Tofacitinib Impurity Tofacitinib Impurity 2504210-41-5 C29H38N10O2
tert-butyl 2-((4R,6S)-6-((E)-2-(4-(3-fluorophenyl)-6-isopropyl-2-(N- methylmethylsulfonamido)pyrimidin-5-yl)vinyl)-2,2-dimethyl-1,3- dioxan-4-yl)acetate tert-butyl 2-((4R,6S)-6-((E)-2-(4-(3-fluorophenyl)-6-isopropyl-2-(N- methylmethylsulfonamido)pyrimidin-5-yl)vinyl)-2,2-dimethyl-1,3- dioxan-4-yl)acetate
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
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
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
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