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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'-[(1H-Tetrazol-5-yl)biphenyl-4-yl]Methanol 2'-[(1H-Tetrazol-5-yl)biphenyl-4-yl]Methanol 160514-13-6 C14H12N4O
ent-Paroxol ent-Paroxol 389573-45-9 C13H18FNO
Ethyl α-Thioglucopyranoside Ethyl α-Thioglucopyranoside 13533-58-9 C8H16O5S
Febuxostat Acyl-β-D-glucuronide Febuxostat Acyl-β-D-glucuronide 1351692-92-6 C22H24N2O9S
Keto Bisoprolol Keto Bisoprolol 864544-37-6 C18H29NO5
Olopatadine Carbaldehyde  DISCONTINUED Olopatadine Carbaldehyde DISCONTINUED 1376615-97-2 C21H23NO2
5-Chloro-1-methyl-4-nitroimidazole 5-Chloro-1-methyl-4-nitroimidazole C4H4ClN3O2
Nisoldipine Related Compound  II Nisoldipine Related Compound II
2-Butyl-1,6-dihydro-N,N,4-trimethyl-6-oxo-1-[[2'-[1-(triphenylmethyl)-1H-tetrazol-5-yl][1,1'-biphenyl]-4-yl]methyl]-5-pyrimidineacetamide 2-Butyl-1,6-dihydro-N,N,4-trimethyl-6-oxo-1-[[2'-[1-(triphenylmethyl)-1H-tetrazol-5-yl][1,1'-biphenyl]-4-yl]methyl]-5-pyrimidineacetamide 503155-67-7 C46H45N7O2
O-De(3-fluorobenzyl) Lapatinib O-De(3-fluorobenzyl) Lapatinib 1268997-70-1 C22H21ClN4O4S
5-Des[2-(tert-butylaMino)] BaMbuterol-5-ethylenediol 5-Des[2-(tert-butylaMino)] BaMbuterol-5-ethylenediol 112935-92-9 C14H20N2O6
Desloratadine Epoxide Desloratadine Epoxide 1346604-23-6 C19H19ClN2O
Menaquinone 4 2,3-Epoxide Menaquinone 4 2,3-Epoxide 72908-86-2 C31H40O3
D-Phenylalanyl Nateglinide D-Phenylalanyl Nateglinide 944746-48-9 C28H36N2O4
Felodipine 3,5-DiMethyl Ester Felodipine 3,5-DiMethyl Ester 91189-59-2 C17H17Cl2NO4
1-BENZYL-N,4-DIMETHYLPIPERIDIN-3-AMINE DIHYDROCHLORIDE 1-BENZYL-N,4-DIMETHYLPIPERIDIN-3-AMINE DIHYDROCHLORIDE 384338-23-2 C14H22N2
(R,Z)-2-((R)-((Z)-2-(2-aMinothiazol-4-yl)-2-(hydroxyiMino)acetaMido)(carboxy)Methyl)-5-ethylidene-5,6-dihydro-2H-1,3-thiazine-4-carboxylic acid (R,Z)-2-((R)-((Z)-2-(2-aMinothiazol-4-yl)-2-(hydroxyiMino)acetaMido)(carboxy)Methyl)-5-ethylidene-5,6-dihydro-2H-1,3-thiazine-4-carboxylic acid 178422-39-4 C14H15N5O6S2
Acyclovir IMpurity C Acyclovir IMpurity C 91702-61-3 C8H11N5O3
Nicergoline-5-Chloro Analogue Nicergoline-5-Chloro Analogue 38536-28-6 C24H26ClN3O3
1-(3-aMino-5-(benzyloxy)-2-hydroxyphenyl)ethanone 1-(3-aMino-5-(benzyloxy)-2-hydroxyphenyl)ethanone 861841-90-9 C15H15NO3
(2RS)-2-Hydroxy-2-[4-(2-Methylpropyl)phenyl]propanoic Acid (2RS)-2-Hydroxy-2-[4-(2-Methylpropyl)phenyl]propanoic Acid C13H18O3
(3RS)-1,3-Bis[4-(2-Methylpropyl) phenyl]butan-1-one (3RS)-1,3-Bis[4-(2-Methylpropyl) phenyl]butan-1-one C24H32O
2-[4-(2-Methylpropyl)phenyl] ethanol 2-[4-(2-Methylpropyl)phenyl] ethanol 2143535-25-3 C24H32O
1-cyclopropyl-6-fluoro-8-hydroxy-4-oxo-7-((4aR,7aR)-tetrahydro-1H-pyrrolo[3,4-b]pyridin-6(2H,7H,7aH)-yl)-1,4-dihydroquinoline-3-carboxylic acid hydrobroMide 1-cyclopropyl-6-fluoro-8-hydroxy-4-oxo-7-((4aR,7aR)-tetrahydro-1H-pyrrolo[3,4-b]pyridin-6(2H,7H,7aH)-yl)-1,4-dihydroquinoline-3-carboxylic acid hydrobroMide 1292904-74-5 C20H23BrFN3O4
IMp. B (EP) IMp. B (EP)
IMp. K (EP) IMp. K (EP) 40610-41-1 C13H17NO3
(Z)-Methyl 3-((2'-(N'-hydroxycarbaMiMidoyl)biphenyl-4-yl)Methyl)-2-oxo-2,3-dihydro-1H-benzo[d]iMidazole-4-carboxylate (Z)-Methyl 3-((2'-(N'-hydroxycarbaMiMidoyl)biphenyl-4-yl)Methyl)-2-oxo-2,3-dihydro-1H-benzo[d]iMidazole-4-carboxylate 1499167-72-4 C23H20N4O4
4-(4-fluorobenzoyl)-3-(hydroxyMethyl)benzonitrile 4-(4-fluorobenzoyl)-3-(hydroxyMethyl)benzonitrile 260371-16-2 C15H10FNO2
ATV-FX1 sodiuM salt ATV-FX1 sodiuM salt 1315629-79-8 C33H34FN2NaO7
Montelukast Impurity H Montelukast Impurity H 851755-56-1 C34H32ClNO4S
SalMeterol EP IMpurity F SalMeterol EP IMpurity F 1391054-40-2 C25H37NO3
[6-Hydroxy-2-(4-hydroxyphenyl)benzo[b]thiophen-7-yl] [6-Hydroxy-2-(4-hydroxyphenyl)benzo[b]thiophen-7-yl] 1391054-73-1 C28H27NO4S
(R)-α-Methyl-N-[3-[3-(trifluoroMethyl)phenyl]Methyl]-1-naphthaleneMethaneaMine Hydrochloride (R)-α-Methyl-N-[3-[3-(trifluoroMethyl)phenyl]Methyl]-1-naphthaleneMethaneaMine Hydrochloride 1229225-42-6 C20H19ClF3N
3(S)-Hydroperoxy Simvastatin 3(S)-Hydroperoxy Simvastatin 1092716-44-3 C25H38O7
2(RS)-4-Methyl-1-(3-Methylpyridin-2-yl)-2-phenylpiperazine 2(RS)-4-Methyl-1-(3-Methylpyridin-2-yl)-2-phenylpiperazine 191546-94-8 C17H21N3
AgoMelatine DiMer Urea AgoMelatine DiMer Urea 185421-27-6 C27H28N2O3
AgoMelatine DiMer Urea AgoMelatine DiMer Urea 185421-27-6 C27H28N2O3
Isotachysterol3 Isotachysterol3 22350-43-2 C27H44O
Nitrendipine Propyl Ester Nitrendipine Propyl Ester 225785-54-6 C19H22N2O6
O-DesMethyl Urapidil O-DesMethyl Urapidil 91453-03-1 C19H27N5O3
(1R,3R,4R)-Entecavir (1R,3R,4R)-Entecavir 1367369-76-3 C12H15N5O3
5-(5-chloro-1-(2-fluorophenyl)-2-oxopentyl)-4,5,6,7-tetrahydrothieno[3,2-c]pyridin-2-yl acetate 5-(5-chloro-1-(2-fluorophenyl)-2-oxopentyl)-4,5,6,7-tetrahydrothieno[3,2-c]pyridin-2-yl acetate 1056459-37-0 C20H21ClFNO3S
(2S,3R)-2-((S)-1-(3,5-bis(trifluoroMethyl)phenyl)ethoxy)-3-(4-fluorophenyl)Morpholine (2S,3R)-2-((S)-1-(3,5-bis(trifluoroMethyl)phenyl)ethoxy)-3-(4-fluorophenyl)Morpholine 327623-37-0 C20H18F7NO2
Linagliptin iMpurity Linagliptin iMpurity 2140263-92-7 C25H28N8O2
1-(2-Fluorobenzyl)-1H-pyrazolo[3,4-b]pyridine-3-carboxaMide 1-(2-Fluorobenzyl)-1H-pyrazolo[3,4-b]pyridine-3-carboxaMide 256376-62-2 C14H11FN4O
Alogliptin iMpurity Alogliptin iMpurity 60271-06-9 C7H10N2O3
Alogliptin iMpurity Alogliptin iMpurity 60271-06-9 C7H10N2O3
cefaclor iMpurity H cefaclor iMpurity H C4H6N4O3S2
Tadalafil iMpurity E Tadalafil iMpurity E
3,3',5-TRIIODOTHYROPROPIONIC ACID 3,3',5-TRIIODOTHYROPROPIONIC ACID 51-26-3 C15H11I3O4
Cytidine,N-benzoyl-2^-C-Methyl-,3^,5^-dibenzoate(9CI) Cytidine,N-benzoyl-2^-C-Methyl-,3^,5^-dibenzoate(9CI) 863329-64-0 C31H27N3O8
(R)-2-((6-(3-((3-(2-cyanobenzyl)-1-Methyl-2,6-dioxo-1,2,3,6-tetrahydropyriMidin-4-yl)aMino)piperidin-1-yl)-3-Methyl-2,4-dioxo-3,4-dihydropyriMidin-1(2H)-yl)Methyl)benzonitrile (R)-2-((6-(3-((3-(2-cyanobenzyl)-1-Methyl-2,6-dioxo-1,2,3,6-tetrahydropyriMidin-4-yl)aMino)piperidin-1-yl)-3-Methyl-2,4-dioxo-3,4-dihydropyriMidin-1(2H)-yl)Methyl)benzonitrile 1268836-55-0 C31H30N8O4
(R)-2-((6-(3-((3-(2-cyanobenzyl)-1-Methyl-2,6-dioxo-1,2,3,6-tetrahydropyriMidin-4-yl)aMino)piperidin-1-yl)-3-Methyl-2,4-dioxo-3,4-dihydropyriMidin-1(2H)-yl)Methyl)benzonitrile (R)-2-((6-(3-((3-(2-cyanobenzyl)-1-Methyl-2,6-dioxo-1,2,3,6-tetrahydropyriMidin-4-yl)aMino)piperidin-1-yl)-3-Methyl-2,4-dioxo-3,4-dihydropyriMidin-1(2H)-yl)Methyl)benzonitrile 1268836-55-0 C31H30N8O4
1-Pyrrolidinecarboxylic acid, 4-oxo-2-(3-thiazolidinylcarbonyl)-, 1,1-diMethylethyl ester, (2R)- 1-Pyrrolidinecarboxylic acid, 4-oxo-2-(3-thiazolidinylcarbonyl)-, 1,1-diMethylethyl ester, (2R)- 1415908-67-6 C13H20N2O4S
ACETAMINOPHEN IMPURITY B ACETAMINOPHEN IMPURITY B 1693-37-4 C9H11NO2
2-chloro-N-(3-chloro-2-methylphenyl)nicotinamide 2-chloro-N-(3-chloro-2-methylphenyl)nicotinamide 57841-61-9 C13H10Cl2N2O
(R)-3-Amino-3-phenylpropionic acid (R)-3-Amino-3-phenylpropionic acid 13921-90-9 C9H11NO2
4-(2-Ethoxy benzamido)-1-methyl-3-n-propyl pyrazole-5-carboxamide. 4-(2-Ethoxy benzamido)-1-methyl-3-n-propyl pyrazole-5-carboxamide. 139756-03-9 C17H22N4O3
N-Hydroxy Riluzole N-Hydroxy Riluzole 179070-90-7 C8H5F3N2O2S
2-piperazine-4-amino-6,7-dimethoxyquinazoline Hydrochloride 2-piperazine-4-amino-6,7-dimethoxyquinazoline Hydrochloride 70843-11-7 C14H20ClN5O2
3-[(E)-Ethylidene]-2-pyrrolidone 3-[(E)-Ethylidene]-2-pyrrolidone 930-94-9
1-(3-Aminopropyl)aziridine 1-(3-Aminopropyl)aziridine 1072-65-7 C5H12N2
3,5-Di(4-pyridinyl)-1H-1,2,4-triazol-1-amine 3,5-Di(4-pyridinyl)-1H-1,2,4-triazol-1-amine 4923-06-2 C12H10N6
(1α,2β,4β,5α)-9-Methyl-3-oxa-9-azatricyclo[3.3.1.02,4]nonan-7α-ol (1α,2β,4β,5α)-9-Methyl-3-oxa-9-azatricyclo[3.3.1.02,4]nonan-7α-ol 498-46-4 C8H13NO2
Ambroxol EP Impurity B Ambroxol EP Impurity B 18683-95-9 C14H18Br2N2O
16-Hydroxyerythromycin 16-Hydroxyerythromycin 82230-93-1 C37H67NO14
BUPROPION MORPHOLINOL BUPROPION MORPHOLINOL 357399-43-0 C13H18ClNO2
4-[1-(4-Chlorophenyl)-1-phenylethoxy]-1-methylhexahydro-1H-azepine 4-[1-(4-Chlorophenyl)-1-phenylethoxy]-1-methylhexahydro-1H-azepine 61771-18-4 C21H26ClNO
1,4-Dihydro-2,6-dimethyl-4-(3-nitrophenyl)pyridine-3,5-dicarboxylic acid 3-isopropyl 5-(2-hydroxyethyl) ester 1,4-Dihydro-2,6-dimethyl-4-(3-nitrophenyl)pyridine-3,5-dicarboxylic acid 3-isopropyl 5-(2-hydroxyethyl) ester 82219-47-4 C20H24N2O7
3-[(3-TRIFLUOROMETHYL)PHENYL]-1-PROPENE 3-[(3-TRIFLUOROMETHYL)PHENYL]-1-PROPENE 1813-96-3 C10H9F3
(AS)-A-(2-CHLOROPHENYL)-2,3,6,7-TETRAHYDRO-2-OXO-THIENO[3,2-C]PYRIDINE-5(4H)-ACETIC ACID METHYL ESTER (AS)-A-(2-CHLOROPHENYL)-2,3,6,7-TETRAHYDRO-2-OXO-THIENO[3,2-C]PYRIDINE-5(4H)-ACETIC ACID METHYL ESTER 527687-26-9 C16H16ClNO3S
1-(P-METHOXYPHENYL)-1-BUTEN-3-ONE 1-(P-METHOXYPHENYL)-1-BUTEN-3-ONE 943-88-4 C11H12O2
ANAGRELIDE IMPURITY 5 ANAGRELIDE IMPURITY 5 444904-63-6 C8H7Cl2N3
ANAGRELIDE IMPURITY 5 ANAGRELIDE IMPURITY 5 444904-63-6 C8H7Cl2N3
REF DUPL: trans-2-Hydroxymethyl-5-(cytosin-1-yl)-1,3-oxathiolane REF DUPL: trans-2-Hydroxymethyl-5-(cytosin-1-yl)-1,3-oxathiolane 139757-68-9 C8H11N3O3S
(S)-N-Didemethyl Dapoxetine (S)-N-Didemethyl Dapoxetine 147199-40-4 C19H19NO
Hydroxy Flunarizine Hydroxy Flunarizine 87166-81-2 C26H26F2N2O
1-METHYL-4-NITRO-3-PROPYL-1H-PYRAZOLE-5-CARBOXYLIC ACID 1-METHYL-4-NITRO-3-PROPYL-1H-PYRAZOLE-5-CARBOXYLIC ACID 139756-00-6 C8H11N3O4
Allopurinol Related CoMpound F Allopurinol Related CoMpound F 321571-07-7 C12H14N4O4
N-[(n-butylaMino)carbonyl]-4-[(3-Methylphenyl)aMino]-3-pyridinesulfonaMide N-[(n-butylaMino)carbonyl]-4-[(3-Methylphenyl)aMino]-3-pyridinesulfonaMide 160972-33-8 C17H22N4O3S
(R)-N-DeMethyl Dapoxetine (R)-N-DeMethyl Dapoxetine 1202160-36-8 C20H21NO
(2R,3S)-2-[(1R)-1-[3,5-Bis(trifluoroMethyl)phenyl]ethoxy]-3-(phenyl)Morpholine hydrochloride (2R,3S)-2-[(1R)-1-[3,5-Bis(trifluoroMethyl)phenyl]ethoxy]-3-(phenyl)Morpholine hydrochloride 874460-46-5 C20H20ClF6NO2
AlMotriptan iMpurity AlMotriptan iMpurity
AlMotriptan iMpurity AlMotriptan iMpurity
FaMotidine iMpurity FaMotidine iMpurity 130463-35-3 C5H8N4S2.Na
Nitrendipine iMpurity Nitrendipine iMpurity
TraMadol EP IMpurity-C TraMadol EP IMpurity-C 66170-31-8 C16H24ClNO
tert-Butyl [(1R,2S,5S)-2-amino-5-[(dimethylamino)carbonyl]cyclohexyl]carbamate oxalate tert-Butyl [(1R,2S,5S)-2-amino-5-[(dimethylamino)carbonyl]cyclohexyl]carbamate oxalate 1210348-34-7 C16H29N3O7
Anastrozole IMpurity (3-(1-Cyano-1-Methylethyl)-alfa,alfa-diMethyl-5-(1H-,1,2,4-triazole-1-ylMethyl)-benzeneacetic acid) Anastrozole IMpurity (3-(1-Cyano-1-Methylethyl)-alfa,alfa-diMethyl-5-(1H-,1,2,4-triazole-1-ylMethyl)-benzeneacetic acid) 1338800-82-0 C17H20N4O2
Anastrozole IMpurity (3-(1-Cyano-1-Methylethyl)-alfa,alfa-diMethyl-5-(1H-,1,2,4-triazole-1-ylMethyl)-benzeneacetic acid) Anastrozole IMpurity (3-(1-Cyano-1-Methylethyl)-alfa,alfa-diMethyl-5-(1H-,1,2,4-triazole-1-ylMethyl)-benzeneacetic acid) 1338800-82-0 C17H20N4O2
AtracuriuM IMpurity K (Mixture of cis, trans, cis, cis(K1 & K2), tans, trans IsoMer) AtracuriuM IMpurity K (Mixture of cis, trans, cis, cis(K1 & K2), tans, trans IsoMer)
ChlorphenaMine IMpurity B ChlorphenaMine IMpurity B
Clozapine EP IMpurity D Clozapine EP IMpurity D 65514-71-8 C18H21ClN4O
Febuxostat IMpurity (2-(3-carboxy-4-isobutyloxyphenyl)-4-Methylthiazole-5-carboxylic acid) Febuxostat IMpurity (2-(3-carboxy-4-isobutyloxyphenyl)-4-Methylthiazole-5-carboxylic acid)
Fluconazole IMpurity I Fluconazole IMpurity I C13H12F2N6O
IMidafenacin Related CoMpound 1 (4-(1H-IMidzol-1-yl)-2,2-DiphenylbutanaMide) IMidafenacin Related CoMpound 1 (4-(1H-IMidzol-1-yl)-2,2-DiphenylbutanaMide) 170105-20-1 C19H19N3O
IMidafenacin Related CoMpound 6 (4-AcetiMidoylaMino-2,2-DiphenylbutanaMide) IMidafenacin Related CoMpound 6 (4-AcetiMidoylaMino-2,2-DiphenylbutanaMide) 503598-33-2 C18H21N3O
Lansoprazole IMpurity H Lansoprazole IMpurity H 1346598-28-4 C23H16F3N5OS
LevetiracetaM IMurity (L-2-AMinobutanaMide HCl,S-2-AMinobutanaMide HCl) LevetiracetaM IMurity (L-2-AMinobutanaMide HCl,S-2-AMinobutanaMide HCl) 1933471-30-7 C8H14N2O3
Milrinone IMpurity 4 Milrinone IMpurity 4
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