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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
Verapamil Related Compound A (50 mg) (3,4-Dimethoxy-alpha-[3-(methylamino)propyl]-alpha-(1-methylethyl)-benzeneacetonitrile monohydrochloride) Verapamil Related Compound A (50 mg) (3,4-Dimethoxy-alpha-[3-(methylamino)propyl]-alpha-(1-methylethyl)-benzeneacetonitrile monohydrochloride) 67775-97-7 C17H27ClN2O2
Ethanediamide, N1-(5-chloro-2-pyridinyl)-N2-[(1R,2S,4R)-4-[(dimethylamino)carbonyl]-2-[[(4,5,6,7-tetrahydro-5-methylthiazolo[5,4-c]pyridin-2-yl)carbonyl]amino]cyclohexyl]- Ethanediamide, N1-(5-chloro-2-pyridinyl)-N2-[(1R,2S,4R)-4-[(dimethylamino)carbonyl]-2-[[(4,5,6,7-tetrahydro-5-methylthiazolo[5,4-c]pyridin-2-yl)carbonyl]amino]cyclohexyl]- 1255529-23-7 C24H30ClN7O4S
4-[4-(diMethylaMino)-1-(4-fluorophenyl)-1-buten-1-yl]-3-(hydroxyMethyl)-benzonitrile (CitalopraM Olefinic IMpurity) 4-[4-(diMethylaMino)-1-(4-fluorophenyl)-1-buten-1-yl]-3-(hydroxyMethyl)-benzonitrile (CitalopraM Olefinic IMpurity) 920282-75-3 C20H21FN2O
Sofosbuvir Impurity Sofosbuvir Impurity 1233335-82-4 C16H25FN3O9P
Ethyl 3,4-O-isopropylideneshikiMate Ethyl 3,4-O-isopropylideneshikiMate 136994-78-0 C12H18O5
4-Vinyl-piperidine-4-carboxylic acid ethyl ester 4-Vinyl-piperidine-4-carboxylic acid ethyl ester 1509910-91-1 C10H17NO2
(2R,4S)-5-([1,1'-biphenyl]-4-yl)-4-aMino-2-Methylpentanoic acid (2R,4S)-5-([1,1'-biphenyl]-4-yl)-4-aMino-2-Methylpentanoic acid 1039307-95-3 C18H21NO2
EMpagliflozin  iMpurity 16 EMpagliflozin iMpurity 16
((R)-2-biphenyl-4-yl-1-forMylethyl)carbaMic acid t-butyl ester ((R)-2-biphenyl-4-yl-1-forMylethyl)carbaMic acid t-butyl ester 149709-58-0 C20H23NO3
1-(2,3-DiMethylphenyl)-1-(1H-iMidazol-4-yl)ethanol 1-(2,3-DiMethylphenyl)-1-(1H-iMidazol-4-yl)ethanol 86347-12-8 C13H16N2O
(R)-3-((R)-5-(4-fluorophenyl)-5-hydroxypentanoyl)-4-phenyloxazolidin-2-one (R)-3-((R)-5-(4-fluorophenyl)-5-hydroxypentanoyl)-4-phenyloxazolidin-2-one 1612153-32-8 C20H20FNO4
(S)-3-((R)-5-(4-fluorophenyl)-5-hydroxypentanoyl)-4-phenyloxazolidin-2-one (S)-3-((R)-5-(4-fluorophenyl)-5-hydroxypentanoyl)-4-phenyloxazolidin-2-one 528565-93-7 C20H20FNO4
Posaconazole iMpurity 3 Posaconazole iMpurity 3
AMoxicillin IMpurity G AMoxicillin IMpurity G C16H19N3O5S
IMp. A (EP): Ethyl 4-[(11RS)-8-Chloro-11-hydroxy-6,11-dihydro-5H-benzo[5,6]cyclohepta[1,2-b]pyridin-11-yl]piperidine-1-carboxylate IMp. A (EP): Ethyl 4-[(11RS)-8-Chloro-11-hydroxy-6,11-dihydro-5H-benzo[5,6]cyclohepta[1,2-b]pyridin-11-yl]piperidine-1-carboxylate 38092-95-4 C19H20N2
PeMetrexed EP IMpurity E PeMetrexed EP IMpurity E 182009-04-7 C20H21N5O6
Itraconazole iMpurity A Itraconazole iMpurity A
(S)-BoroLeu-(-)-Pinanediol-CF3COOH (S)-BoroLeu-(-)-Pinanediol-CF3COOH 477254-69-6 C17H29BF3NO4
Palonosetron Palonosetron 135729-56-5 C19H22N2O
EthanediaMide, N1-(5-chloro-2-pyridinyl)-N2-[(1R,2S,4S)-4-[(diMethylaMino)carbonyl]-2-[[(4,5,6,7-tetrahydro-5-Methylthiazolo[5,4-c]pyridin-2-yl)carbonyl]aMino]cyclohexyl]- EthanediaMide, N1-(5-chloro-2-pyridinyl)-N2-[(1R,2S,4S)-4-[(diMethylaMino)carbonyl]-2-[[(4,5,6,7-tetrahydro-5-Methylthiazolo[5,4-c]pyridin-2-yl)carbonyl]aMino]cyclohexyl]- 1255529-25-9 C24H30ClN7O4S
N-((3R,4R)-1-benzyl-4-Methylpiperidin-3-yl)-2-chloro-N-Methyl-7H-pyrrolo[2,3-d]pyriMidin-4-aMine N-((3R,4R)-1-benzyl-4-Methylpiperidin-3-yl)-2-chloro-N-Methyl-7H-pyrrolo[2,3-d]pyriMidin-4-aMine 923036-25-3 C20H24ClN5
8-Chloro-11-(piperidin-4-ylidene)-11H-benzo[5,6]cyclohepta[1,2-b]pyridine 8-Chloro-11-(piperidin-4-ylidene)-11H-benzo[5,6]cyclohepta[1,2-b]pyridine 117811-20-8 C19H17ClN2
Butanedioic acid, 2,3-dihydroxy- (2R,3R)-, MonoMethyl ester Butanedioic acid, 2,3-dihydroxy- (2R,3R)-, MonoMethyl ester 3333-46-8 C5H8O6
Valsartan D9 Valsartan D9 1089736-73-1 C24H29N5O3
N-((3S,4S)-1-benzyl-4-Methylpiperidin-3-yl)-N-Methyl-7H-pyrrolo[2,3-d]pyriMidin-4-aMine N-((3S,4S)-1-benzyl-4-Methylpiperidin-3-yl)-N-Methyl-7H-pyrrolo[2,3-d]pyriMidin-4-aMine 1252883-90-1 C20H25N5
P219490 P219490 937370-10-0 C20H21N5Na2O6**
(S)-4-(TERT-BUTOXY)-2-ISOPROPYL-4-OXOBUTANOIC ACID (S)-4-(TERT-BUTOXY)-2-ISOPROPYL-4-OXOBUTANOIC ACID 134807-43-5 C11H20O4
Acarbose D-Fructose IMpurity Acarbose D-Fructose IMpurity 1013621-79-8 C25H43NO18
2,4,6,8-Tetraoxa-5-phosphanonanedioic acid, 5-[[(1R)-2-(6-aMino-9H-purin-9-yl)-1-Methylethoxy]Methyl]-, 1-ethyl 9-(1-Methylethyl) ester, 5-oxide 2,4,6,8-Tetraoxa-5-phosphanonanedioic acid, 5-[[(1R)-2-(6-aMino-9H-purin-9-yl)-1-Methylethoxy]Methyl]-, 1-ethyl 9-(1-Methylethyl) ester, 5-oxide 1422284-16-9 C18H28N5O10P
(R)-α-[2-(1-naphthalenyloxy)ethyl]-benzeneMethanol (R)-α-[2-(1-naphthalenyloxy)ethyl]-benzeneMethanol 156453-53-1 C19H18O2
(1S,2S,3R,5S)-3-(7-((1S,2R)-2-(3,4-difluorophenyl)cyclopropylaMino)-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-((1S,2R)-2-(3,4-difluorophenyl)cyclopropylaMino)-5-(propylthio)-3H-[1,2,3]triazolo[4,5-d]pyriMidin-3-yl)-5-(2-hydroxyethoxy)cyclopentane-1,2-diol 2096989-56-7 C23H28F2N6O4S
Fosaprepitant iMpurity Fosaprepitant iMpurity
Apixaban iMpurity 1 Apixaban iMpurity 1
Azilsartan iMpurity H Azilsartan iMpurity H
Azilsartan iMpurity M Azilsartan iMpurity M
bortezoMib iMpurity F bortezoMib iMpurity F
2-(2-(4-(Dibenzo[b,f][1,4]thiazepin-11-yl)piperazin-1-yl)ethoxy)ethyl Acetate 2-(2-(4-(Dibenzo[b,f][1,4]thiazepin-11-yl)piperazin-1-yl)ethoxy)ethyl Acetate 844639-07-2 C23H27N3O3S
4-O-DesMethyl 4-O-Ethyl TriMethopriM 4-O-DesMethyl 4-O-Ethyl TriMethopriM 78025-68-0 C15H20N4O3
1-[[(2E)-3-Phenyl-2-propen-1-yl]oxy]naphthalene 1-[[(2E)-3-Phenyl-2-propen-1-yl]oxy]naphthalene 1091626-77-5 C19H16O
α-[[[2-(4-Methoxyphenyl)-1-Methylethyl](phenylMethyl)aMino]Methyl]-3-nitro-4-(phenylMethoxy)benzeneMethanol α-[[[2-(4-Methoxyphenyl)-1-Methylethyl](phenylMethyl)aMino]Methyl]-3-nitro-4-(phenylMethoxy)benzeneMethanol 43229-67-0 C32H34N2O5
Indacaterol IMrity Indacaterol IMrity 1235445-80-3 C24H28N2O3
Topiroxostat IMpurity Topiroxostat IMpurity
Flurbiprofen Impurity 17 Flurbiprofen Impurity 17 1206101-29-2 C24H16F2
Azilsartan Impurity Azilsartan Impurity 1586011-04-2 C26H25N3O4
1,2-Bis(piperazin-1-yl)benzene 1,2-Bis(piperazin-1-yl)benzene 1446750-99-7 C14H22N4
7-Methoxy-4-oxo-1,4-dihydroquinoline-6-carboxylic acid 7-Methoxy-4-oxo-1,4-dihydroquinoline-6-carboxylic acid 417721-34-7 C11H9NO4
Pemetrexed Pemetrexed
Venlafaxine Venlafaxine C17H27NO2
(S)-4,5-dichloro-N-((2-oxo-3-(4-(3-oxoMorpholino)phenyl)oxazolidin-5-yl)Methyl)thiophene-2-carboxaMide (S)-4,5-dichloro-N-((2-oxo-3-(4-(3-oxoMorpholino)phenyl)oxazolidin-5-yl)Methyl)thiophene-2-carboxaMide 1770812-37-7 C19H17Cl2N3O5S
2-Propen-1-one, 1-[4-[4-aMino-3-(4-phenoxyphenyl)-1H-pyrazolo[3,4-d]pyriMidin-1-yl]-1-piperidinyl]- 2-Propen-1-one, 1-[4-[4-aMino-3-(4-phenoxyphenyl)-1H-pyrazolo[3,4-d]pyriMidin-1-yl]-1-piperidinyl]- 936563-92-7 C25H24N6O2
8-cyclopentyl-5-Methyl-2-((5-(piperazin-1-yl)pyridin-2-yl)aMino)-6-vinylpyrido[2,3-d]pyriMidin-7(8H)-one 8-cyclopentyl-5-Methyl-2-((5-(piperazin-1-yl)pyridin-2-yl)aMino)-6-vinylpyrido[2,3-d]pyriMidin-7(8H)-one C24H29N7O
D-Alanine, N-[[P(R),2'R]-2'-deoxy-2'-fluoro-2'-Methyl-P-phenyl-5'-uridylyl]-, 1-Methylethyl ester D-Alanine, N-[[P(R),2'R]-2'-deoxy-2'-fluoro-2'-Methyl-P-phenyl-5'-uridylyl]-, 1-Methylethyl ester 1496552-16-9 C22H29FN3O9P
D-Phenylalanine, N-[(1,1-diMethylethoxy)carbonyl]-L-leucyl-, Methyl ester D-Phenylalanine, N-[(1,1-diMethylethoxy)carbonyl]-L-leucyl-, Methyl ester 15136-32-0 C21H32N2O5
4-Nitro-2-phenoxyphenol 4-Nitro-2-phenoxyphenol 70995-08-3 C12H9NO4
cefoxitin iMpurity A cefoxitin iMpurity A
4-(2-Aminophenyl)-3-morpholinone 4-(2-Aminophenyl)-3-morpholinone 1082588-73-5 C10H12N2O2
(R)-N-(1-(naphthalen-1-yl)ethyl)-3-(4-(trifluoroMethyl)phenyl)propan-1-aMine (R)-N-(1-(naphthalen-1-yl)ethyl)-3-(4-(trifluoroMethyl)phenyl)propan-1-aMine 1428185-71-0 C22H22F3N
1-Piperidinepropanenitrile, 4-Methyl-3-(Methyl-7H-pyrrolo[2,3-d]pyriMidin-4-ylaMino)-β-oxo- 1-Piperidinepropanenitrile, 4-Methyl-3-(Methyl-7H-pyrrolo[2,3-d]pyriMidin-4-ylaMino)-β-oxo- 344418-92-4 C16H20N6O
Erlotinib impurity A Erlotinib impurity A 183321-85-9 C21H20ClN3O3
1,3-Dioxane-4,6-dione, 5-[[(3,4-diMethoxyphenyl)aMino]Methylene]-2,2-diMethyl- 1,3-Dioxane-4,6-dione, 5-[[(3,4-diMethoxyphenyl)aMino]Methylene]-2,2-diMethyl- 213699-53-7 C15H17NO6
(2R,3R)-2-[(1S)-1-[3,5-Bis(trifluoroMethyl)phenyl]ethoxy]-3-(4-fluorophenyl)Morpholine hydrochloride (2R,3R)-2-[(1S)-1-[3,5-Bis(trifluoroMethyl)phenyl]ethoxy]-3-(4-fluorophenyl)Morpholine hydrochloride 1333998-21-2 C20H19ClF7NO2
Budesonide iMpurity Budesonide iMpurity 192057-49-1 C24H32O6
dextroMethorphan iMpurity dextroMethorphan iMpurity
Fluticasone IMpurity Fluticasone IMpurity 397864-58-3 C27H30F2O6S
Valdecoxib iMpurity Valdecoxib iMpurity
Fluconazole IMpurity-H Fluconazole IMpurity-H
Retigabine Dihydrochloride Impurity Retigabine Dihydrochloride Impurity 1432063-93-8 C16H19ClFN3O2
Adrenaline IMpurity F Adrenaline IMpurity F 78995-75-2 C9H13NO5S
AMpicillin-d5 AMpicillin-d5 1426173-65-0 C16H14D5N3O4S
Anastrozole IMpurity (alfa1 , alfa1, alfa3, alfa3-TetraMethyl-5-(1H-1,2,4-triazol-1-ylMethyl)-1,3-Benzenediacetic acid) Anastrozole IMpurity (alfa1 , alfa1, alfa3, alfa3-TetraMethyl-5-(1H-1,2,4-triazol-1-ylMethyl)-1,3-Benzenediacetic acid) 1338800-81-9 C17H21N3O4
Apixaban IMpurity 4 (BMS-728626-01) Apixaban IMpurity 4 (BMS-728626-01) 1801881-22-0 C27H28N4O5
AtracuriuM IMpurity C1 (trans-Monoacrylate) AtracuriuM IMpurity C1 (trans-Monoacrylate)
AzithroMycin IMpurity C AzithroMycin IMpurity C
AztreonaM IMpurity D AztreonaM IMpurity D
Busulfan IMpurity 1 Busulfan IMpurity 1 1797106-48-9 C6H14O5S2
Deferasirox Ethyl Ester Deferasirox Ethyl Ester 201530-79-2 C23H19N3O4
MetoclopraMide IMpurity F MetoclopraMide IMpurity F 38339-95-6 C13H20ClN3O2
Metronidazole IMpurity E Metronidazole IMpurity E
Propofol IMpurity H Propofol IMpurity H
R-(-)-O-DesMethyl-Venlafaxine-d6 R-(-)-O-DesMethyl-Venlafaxine-d6 1062609-96-4 C16H25NO2
Ribavirin IMp. C (EP) Ribavirin IMp. C (EP)
SalMeterol IMpurity B SalMeterol IMpurity B C25H37NO4
Sitagliptin N-Phoshate IMpurity Sitagliptin N-Phoshate IMpurity 1351498-25-3 C16H16F6N5O4P
SulbactaM IMpurity E SulbactaM IMpurity E
TriMethopriM IMpurity A TriMethopriM IMpurity A 213745-86-9 C15H20N4O3
Varenicline Metadinitro IMpurity Varenicline Metadinitro IMpurity
1-(4-methoxyphenyl)-2-methylpropan-2-amine 1-(4-methoxyphenyl)-2-methylpropan-2-amine 56490-94-9 C11H17NO
product/153101 product/153101
2-Methyl-5,6-dihydro-4H-benzo[b]oxazolo[5,4-d]azepine 2-Methyl-5,6-dihydro-4H-benzo[b]oxazolo[5,4-d]azepine 877858-27-0 C12H12N2O
Miconazole IMpurity H Miconazole IMpurity H 181931-30-6 C18H16Cl2N2O
Apixaban IMpurity(BMS-778960-01) Apixaban IMpurity(BMS-778960-01)
1,3,5-Tri-O-benzoyl-2-deoxy-2-fluoro-α-D-ribofuranose 1,3,5-Tri-O-benzoyl-2-deoxy-2-fluoro-α-D-ribofuranose 704916-12-1 C26H21FO7
Chlorpheniramine Chlorpheniramine 78539-96-5 C16H19ClN2
9-(2,5-d|Dioxo-L-3-aMino-1-pyrrolidineacetic acid)-10-deglycine DaptoMycin 9-(2,5-d|Dioxo-L-3-aMino-1-pyrrolidineacetic acid)-10-deglycine DaptoMycin 121869-35-0 C72H99N17O25
(1S,2S,5S)-4-[2-[2-(6,6-DiMethylbicyclo[3.1.1]hept-2-yl)ethoxy]ethyl]Morpholine (1S,2S,5S)-4-[2-[2-(6,6-DiMethylbicyclo[3.1.1]hept-2-yl)ethoxy]ethyl]Morpholine 38284-47-8 C17H31NO2
[4-(4-AMino-6-hydroxy-7-Methoxy-2-quinazolinyl)-1-piperazinyl](tetrahydro-2-furanyl)Methanone [4-(4-AMino-6-hydroxy-7-Methoxy-2-quinazolinyl)-1-piperazinyl](tetrahydro-2-furanyl)Methanone 105356-89-6 C18H23N5O4
2,2'-[4-(2-Methylpropoxy)-1,3-phenylene]bis[4-Methyl-5-thiazolecarboxylic Acid 5,5'-DiMethyl Ester 2,2'-[4-(2-Methylpropoxy)-1,3-phenylene]bis[4-Methyl-5-thiazolecarboxylic Acid 5,5'-DiMethyl Ester 1330632-47-7 C22H24N2O5S2
2-(DiethylaMino)-N-(2,4-diMethylphenyl)acetaMide Hydrochloride 2-(DiethylaMino)-N-(2,4-diMethylphenyl)acetaMide Hydrochloride 17289-54-2 C14H23ClN2O
3-(5-Methyl-1H-iMidazol-1-yl)-5-(trifluoroMethyl)benzenaMine 3-(5-Methyl-1H-iMidazol-1-yl)-5-(trifluoroMethyl)benzenaMine 641571-16-6 C11H10F3N3
4-[[3-(4-Methylphenyl)-3-oxo-1-(trifluoroMethyl)propylidene]aMino]benzenesulfonaMide 4-[[3-(4-Methylphenyl)-3-oxo-1-(trifluoroMethyl)propylidene]aMino]benzenesulfonaMide 1061214-09-2 C17H15F3N2O3S
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