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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
Lapatinib IMpurity 10 Lapatinib IMpurity 10 1152131-73-1 C26H17ClFN3O4
Metronidazole IMpurity D Metronidazole IMpurity D
PraMipexole IMpurity V (PraMipexole IMpurity Z) PraMipexole IMpurity V (PraMipexole IMpurity Z)
Prasugrel Acetyl IMpurity Prasugrel Acetyl IMpurity 1443034-67-0 C18H18FNO3S
Propofol IMpurity G Propofol IMpurity G
SalMeterol IMpurity A SalMeterol IMpurity A C25H37NO4
Sitagliptin Defuoro IMpurity 3 Sitagliptin Defuoro IMpurity 3 851307-12-5 C15H19F2NO4
Sitagliptin N-Boc IMpurity Sitagliptin N-Boc IMpurity 486460-23-5 C21H23F6N5O3
SulbactaM IMpurity D SulbactaM IMpurity D
Valsartan N2-Trityl IMpurity Valsartan N2-Trityl IMpurity
Vardenafil IMpurity 3 Vardenafil IMpurity 3 1255919-01-7 C26H30N6O4S
Montelukast Cyclopropaneacetonitrile Montelukast Cyclopropaneacetonitrile 866923-62-8 C35H35ClN2OS
(3R,4R,5R,6S)-2-(acetoxyMethyl)-6-(4-chloro-3-(4-ethoxybenzyl)phenyl)tetrahydro-2H-pyran-3,4,5-triyl triacetate (3R,4R,5R,6S)-2-(acetoxyMethyl)-6-(4-chloro-3-(4-ethoxybenzyl)phenyl)tetrahydro-2H-pyran-3,4,5-triyl triacetate 461432-24-6 C22H27ClO7
Ezetimibe Impurity Ezetimibe Impurity 1510820-22-0 C24H23F2NO2
10,13-bissidechainpaclitaxel 10,13-bissidechainpaclitaxel
Istradefylline Impurity A Istradefylline Impurity A
(3R,4S)-1-benzyl-N,4-diMethylpiperidin-3-aMine dihydrochloride (3R,4S)-1-benzyl-N,4-diMethylpiperidin-3-aMine dihydrochloride C14H24Cl2N2
2-(((3-Methyl-4-nitropyridin-2-yl)Methyl)sulfinyl)-1H- benzo[d]iMidazole 2-(((3-Methyl-4-nitropyridin-2-yl)Methyl)sulfinyl)-1H- benzo[d]iMidazole 142384-07-4 C14H12N4O3S
(9S)-9-Amino-9-deoxoerythromycin (9S)-9-Amino-9-deoxoerythromycin 26116-56-3 C37H70N2O12
Oseltamivir Impurity 124 Oseltamivir Impurity 124
Oseltamivir Impurity 114 Oseltamivir Impurity 114
Avatrombopag Impurity 69 Avatrombopag Impurity 69
(1R,3aS,4E,7aR)-4-[(2E)-2-[(3S,5R)-3,5-bis[[(1,1-dimethylethyl)dimethylsilyl]oxy]-2-methylenecyclohexylidene]ethylidene]octahydro-7a-methyl-1-[(1R,4S)-1,4,5-trimethylhexyl]-1H-Indene (1R,3aS,4E,7aR)-4-[(2E)-2-[(3S,5R)-3,5-bis[[(1,1-dimethylethyl)dimethylsilyl]oxy]-2-methylenecyclohexylidene]ethylidene]octahydro-7a-methyl-1-[(1R,4S)-1,4,5-trimethylhexyl]-1H-Indene 2229745-37-1 C40H74O2Si2
(+)-Tamsulosin (+)-Tamsulosin 106138-88-9 C20H28N2O5S
2-Pyrrolidinecarboxamide,1-(hydroxyacetyl)-,(S)-(9CI) 2-Pyrrolidinecarboxamide,1-(hydroxyacetyl)-,(S)-(9CI) 96166-39-1 C7H12N2O3
1H-Pyrazole,3-ethoxy-5-methyl-1-phenyl-(9CI) 1H-Pyrazole,3-ethoxy-5-methyl-1-phenyl-(9CI) 300543-31-1 C12H14N2O
apiopaeonoside apiopaeonoside 100291-86-9 C20H28O12
(2-PHENOXY)METHYLSULFONYLANILINE (2-PHENOXY)METHYLSULFONYLANILINE 51765-51-6 C13H13NO3S
(S)-Cilastatin EP Impurity G (S)-Cilastatin EP Impurity G
4-methoxy-2,3,5-trimethylpyridine 4-methoxy-2,3,5-trimethylpyridine 109371-19-9 C9H13NO
Lexithromycin Lexithromycin 53066-26-5 C38H70N2O13
Imimidistine impurity B Imimidistine impurity B
methylprednisolone 17-hemisuccinate methylprednisolone 17-hemisuccinate 77074-42-1 C26H34O8
8-hydroxymethylriboflavin 8-hydroxymethylriboflavin 52134-62-0 C17H20N4O7
RS 42358-197 RS 42358-197 135729-55-4 C19H23ClN2O
acetylthiamine acetylthiamine 3419-28-1
deacetylcephalosporin C deacetylcephalosporin C 1476-46-6 C14H19N3O7S
N-nitroso-N-methylcyclohexylamine N-nitroso-N-methylcyclohexylamine 5432-28-0 C7H14N2O
ETHYLVANILLINBETA-D-GLUCOPYRANOSIDE ETHYLVANILLINBETA-D-GLUCOPYRANOSIDE 122397-96-0 C15H20O8
4-(2-Cyanophenyl)benzyl alcohol 4-(2-Cyanophenyl)benzyl alcohol 154709-19-0 C14H11NO
1-Propanol, 3-[[2-[(1H-benzimidazol-2-ylsulfinyl)methyl]-3-methyl-4-pyridinyl]oxy]- 1-Propanol, 3-[[2-[(1H-benzimidazol-2-ylsulfinyl)methyl]-3-methyl-4-pyridinyl]oxy]- 117976-94-0 C17H19N3O3S
2',3'-O-isopropylidene cytidine 2',3'-O-isopropylidene cytidine 362-42-5 C12H17N3O5
4,4''-Dimethoxyazoxybenzene 4,4''-Dimethoxyazoxybenzene 501-58-6 C14H14N2O2
3,5-Dibenzyloxy terbutalline 3,5-Dibenzyloxy terbutalline 28924-25-6 C26H31NO3
1H-BENZIMIDAZOLE,2-CHLORO-1-(2-ETHOXYETHYL) 1H-BENZIMIDAZOLE,2-CHLORO-1-(2-ETHOXYETHYL) 87233-54-3 C11H13ClN2O
LEYBOLD VACUUM PUMP OIL LEYBOLD VACUUM PUMP OIL 64742-65-0
2,2-Dimethyl-4-isopropyl-1,3-benzodioxole (Propofol Impurity L) 2,2-Dimethyl-4-isopropyl-1,3-benzodioxole (Propofol Impurity L) 201166-22-5 C12H16O2
24Dichloro-5methoxyacetanilide 24Dichloro-5methoxyacetanilide 65182-98-1 C9H9Cl2NO2
Valsartan Desvaleryl Impurity Valsartan Desvaleryl Impurity 676129-92-3 C19H21N5O2
Istradefylline iMpurity Istradefylline iMpurity
(E)-Olopatadine Hydrochloride (E)-Olopatadine Hydrochloride 949141-22-4 C21H24ClNO3
(3R,4R,5R)-3-(1-Ethylpropoxy)-4-hydroxy-5-[(Methylsulfonyl)oxy]-1-cyclohexene-1-carboxylic Acid Ethyl Ester (3R,4R,5R)-3-(1-Ethylpropoxy)-4-hydroxy-5-[(Methylsulfonyl)oxy]-1-cyclohexene-1-carboxylic Acid Ethyl Ester 204254-92-2 C15H26O7S
(R)-α-[(2,2-DiMethyl-1-oxopropyl)aMino]-4-hydroxybenzeneacetic Acid (R)-α-[(2,2-DiMethyl-1-oxopropyl)aMino]-4-hydroxybenzeneacetic Acid 205826-86-4 C13H17NO4
(R)-α-[(2,2-DiMethyl-1-oxopropyl)aMino]-4-hydroxybenzeneacetic Acid (R)-α-[(2,2-DiMethyl-1-oxopropyl)aMino]-4-hydroxybenzeneacetic Acid 205826-86-4 C13H17NO4
2-(3-(4-(7H-Pyrrolo[2,3-d]pyrimidin-2-yl)-1H-pyrazol-1-yl)-1-(ethylsulfonyl)azetidin-3-yl)acetonitrile 2-(3-(4-(7H-Pyrrolo[2,3-d]pyrimidin-2-yl)-1H-pyrazol-1-yl)-1-(ethylsulfonyl)azetidin-3-yl)acetonitrile C16H17N7O2S
6-BENZYLAMINOPURINE 9-(§-D-GLUCOSIDE) 6-BENZYLAMINOPURINE 9-(§-D-GLUCOSIDE)
Ipragliflozin Impurity 4 Ipragliflozin Impurity 4
Mupirocin iMpurity 6 Mupirocin iMpurity 6 C26H44O9
Vitamin B1 Impurity 5 Vitamin B1 Impurity 5 2443-50-7 C12H17ClN4OS
Irbesartan IMpurity 16 Irbesartan IMpurity 16 C25H28N6O
479348-49-7 479348-49-7 479348-49-7 C20H19FN2O6
1449029-77-9 1449029-77-9 1449029-77-9 C29H26N4O7
295366-48-2 295366-48-2 295366-48-2 C17H25NO3
(3S,4R)-phenyl 3-((benzo[d][1,3]dioxol-5-yloxy)methyl)-4-phenyl piperidine-1-carboxylate (3S,4R)-phenyl 3-((benzo[d][1,3]dioxol-5-yloxy)methyl)-4-phenyl piperidine-1-carboxylate C26H25NO5
Fluticasone Impurity 13 Fluticasone Impurity 13 C25H31F3O5S
nicergoline impurity K nicergoline impurity K
Clopidogrel Impurity 46 Clopidogrel Impurity 46 1801260-21-8 C25H26ClNO6S
Rosuvastatin Impurity 89 Rosuvastatin Impurity 89 2226413-61-0 C38H46F2N6O9S2
Ibuprofen EP Impurity I Ibuprofen EP Impurity I 2143535-26-4 C13H18O2
Moxifloxacin Impurity 11 Moxifloxacin Impurity 11
Linagliptin Impurity 7 Linagliptin Impurity 7 2416949-69-2 C25H29N7O4
Afatinib Impurity OLQ Afatinib Impurity OLQ
Afatinib Impurity OLQ Afatinib Impurity OLQ
Androstane-3,17-diol,2-(4-morpholinyl)-16-(1-pyrrolidinyl) Androstane-3,17-diol,2-(4-morpholinyl)-16-(1-pyrrolidinyl) 119302-22-6 C31H50N2O5
Landiolol impurity W Landiolol impurity W
Metoprolol IMpurity T Metoprolol IMpurity T C15H25NO3
Teneligliptin Impurity 11 Teneligliptin Impurity 11 2131105-24-1 C25H35N5O4
Teneligliptin Impurity 16 Teneligliptin Impurity 16
IMP-EP-M IMP-EP-M 1193104-80-1 C60H79N2O15S+
Hyoscine Butylbromide EP Impurity H Hyoscine Butylbromide EP Impurity H
2-((4S,6S)-6-(2-aminoethyl)-2,2-dimethyl-1,3-dioxan-4-yl)acetic acid 2-((4S,6S)-6-(2-aminoethyl)-2,2-dimethyl-1,3-dioxan-4-yl)acetic acid 2165770-84-1 C10H19NO4
Androstane-2,17-diol, 3-(4-morpholinyl)-16-(1-pyrrolidinyl)-, (2α,3β,5α,16β,17β)- Androstane-2,17-diol, 3-(4-morpholinyl)-16-(1-pyrrolidinyl)-, (2α,3β,5α,16β,17β)- 1252016-49-1 C27H46N2O3
(S)-N,N-dimethyl-3-((R)-3-(naphthalen-1-yloxy)-1-phenylpropoxy)-1-phenylpropan-1-amine (S)-N,N-dimethyl-3-((R)-3-(naphthalen-1-yloxy)-1-phenylpropoxy)-1-phenylpropan-1-amine C30H33NO2
CetearylGlucosideCetearyl Glucoside CetearylGlucosideCetearyl Glucoside 246159-33-1
Bisoprolol Impurity 40 Bisoprolol Impurity 40
Tegoprazan Impurity 4 Tegoprazan Impurity 4
Valdecoxib N-Oxide Valdecoxib N-Oxide
Olodaterol Impurity 23 Olodaterol Impurity 23
	Miglitol Isomer impurities C Miglitol Isomer impurities C
8-(2,3-dichlorophenyl)-5,8-diazaspiro[4.5]decan-5-ium bromide 8-(2,3-dichlorophenyl)-5,8-diazaspiro[4.5]decan-5-ium bromide 2043655-58-7 C14H19Cl3N2
Alpha-D-Methylglucoside Alpha-D-Methylglucoside
4-Desacetyl Vincristine 4-Desacetyl Vincristine 3704-01-6 C44H54N4O9
	Relugolix Impurity 91 Relugolix Impurity 91
D,L N-Desmethylvenlafaxine D,L N-Desmethylvenlafaxine 149289-30-5 C16H25NO2
PIVALOYLOXYMETHYL 6-AMINOPENICILANATE PIVALOYLOXYMETHYL 6-AMINOPENICILANATE 25031-08-7 C14H22N2O5S
(Z)-2-(11-(3-(dimethylamino)propylidene)-6,11-dihydrodibenzo[b,e]oxepin-2-yl)-3-methylbutanoic acid (Z)-2-(11-(3-(dimethylamino)propylidene)-6,11-dihydrodibenzo[b,e]oxepin-2-yl)-3-methylbutanoic acid
NSC525120 NSC525120 10221-08-6 C8H7Cl3
3-(2-cyanoethyl-(2-hydroxyethyl)amino)propanenitrile 3-(2-cyanoethyl-(2-hydroxyethyl)amino)propanenitrile 6305-56-2 C8H13N3O
TRANS-4-[[(2-AMINOPHENYL)METHYL]AMINO]-CYCLOHEXANOL TRANS-4-[[(2-AMINOPHENYL)METHYL]AMINO]-CYCLOHEXANOL 46727-91-7 C13H20N2O
Citalopram Related Compound F Citalopram Related Compound F
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