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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
Sertraline-d3 hydrochloride Sertraline-d3 hydrochloride C17H15Cl3D3N
(S,R,S,S)-Orlistat (S,R,S,S)-Orlistat 111466-63-8 C29H53NO5
2'-Nor ThiaMine 2'-Nor ThiaMine 7770-93-6 C11H15ClN4OS
N1-Losartanyl-losartan (Losartan IMpurity) N1-Losartanyl-losartan (Losartan IMpurity) 230971-71-8 C44H44Cl2N12O
N2-Losartanyl-losartan (Losartan IMpurity) N2-Losartanyl-losartan (Losartan IMpurity) 230971-72-9 C44H44Cl2N12O
N-Ethoxycarbonyl 7-ADCA N-Ethoxycarbonyl 7-ADCA 72820-16-7 C11H14N2O5S
N-Trityl Candesartan Ethyl Ester N-Trityl Candesartan Ethyl Ester 856414-35-2 C45H38N6O3
3R,4S-4-(4-methoxyphenyl)-1-methylpiperi
dinyl] methanol 3R,4S-4-(4-methoxyphenyl)-1-methylpiperi dinyl] methanol 127017-78-1 C14H21NO2
6H-Purin-6-one, 2-amino-1,9-dihydro-9-[(1R,3S,4R)-4-hydroxy-3-(hydroxymethyl)-2-methylenecyclopentyl]- 6H-Purin-6-one, 2-amino-1,9-dihydro-9-[(1R,3S,4R)-4-hydroxy-3-(hydroxymethyl)-2-methylenecyclopentyl]- 188399-46-4 C12H15N5O3
4,4'-(2-HYDROXY-1,3-PROPANDIYLDIOXY)BIS(2-PHENYLACETAMIDE) 4,4'-(2-HYDROXY-1,3-PROPANDIYLDIOXY)BIS(2-PHENYLACETAMIDE) 141650-31-9 C19H22N2O5
Valsartan cyano analog methyl ester Valsartan cyano analog methyl ester 137863-90-2 C25H30N2O3
(8S)-2-BroMo α-Ergocryptine (8S)-2-BroMo α-Ergocryptine 65700-36-9 C32H40BrN5O5
3-[4-(4-Chlorobenzoyl)phenoxy]-2-butanone (Fenofibrate IMpurity) 3-[4-(4-Chlorobenzoyl)phenoxy]-2-butanone (Fenofibrate IMpurity) 217636-47-0 C17H15ClO3
5-(2-Chlorobenzyl)-thieno[3,2-c]pyridiniuM Chloride 5-(2-Chlorobenzyl)-thieno[3,2-c]pyridiniuM Chloride 53885-64-6 C14H11Cl2NS
ClarithroMycin 9-OxiMe ClarithroMycin 9-OxiMe 103450-87-9 C38H70N2O13
Desloratadine N-Hydroxypiperidine Desloratadine N-Hydroxypiperidine 1193725-73-3 C19H19ClN2O
O-DesMethyl Venlafaxine Cyclic IMpurity O-DesMethyl Venlafaxine Cyclic IMpurity 1346601-55-5 C16H23NO2
rac-cis-2,3-Dichloro Sertraline Hydrochloride rac-cis-2,3-Dichloro Sertraline Hydrochloride 1198084-29-5 C17H18Cl3N
Lasmiditan Impurity 9 Lasmiditan Impurity 9
11β-Hydroperoxy Dienogest 11β-Hydroperoxy Dienogest 106111-43-7 C20H25NO4
6α-Methyl Hydrocortisone 21-Acetate 6α-Methyl Hydrocortisone 21-Acetate 1625-11-2 C24H34O6
Ethyl 3,4-O-Isopropylidene-5-O-methanesulfonylshikimate Ethyl 3,4-O-Isopropylidene-5-O-methanesulfonylshikimate 204254-84-2 C13H20O7S
2-PyrazinecarboxaMide, N,N',N''-[2,4,6-boroxintriyltris[[(1R)-3-Methylbutylidene]iMino[(1S)-2-oxo-1-(phenylMethyl)-2,1-ethanediyl]]]tris- 2-PyrazinecarboxaMide, N,N',N''-[2,4,6-boroxintriyltris[[(1R)-3-Methylbutylidene]iMino[(1S)-2-oxo-1-(phenylMethyl)-2,1-ethanediyl]]]tris- 390800-88-1 C57H69B3N12O9
D-hydroxyphenylglycylamoxicillin) D-hydroxyphenylglycylamoxicillin) 188112-75-6 C24H26N4O7S
Salmeterol Related Compound B (10 mg) (4-{1-Hydroxy-2-[6-(4-phenylbutan-2-yloxy)hexylamino]ethyl}-2-(hydroxymethyl)phenol) Salmeterol Related Compound B (10 mg) (4-{1-Hydroxy-2-[6-(4-phenylbutan-2-yloxy)hexylamino]ethyl}-2-(hydroxymethyl)phenol) 108928-81-0 C25H37NO4
piperacillinylaMpicillin piperacillinylaMpicillin
Celecoxib iMpurity-B Celecoxib iMpurity-B
EMtricitabine iMpurity B EMtricitabine iMpurity B
(S,S)-1,7-diazatricyclo[7.3.0.07,11]dodecane-2,6,8,12-tetrone (S,S)-1,7-diazatricyclo[7.3.0.07,11]dodecane-2,6,8,12-tetrone 14842-41-2 C10H10N2O4
1-Hydroxy-7-Methoxy-1,2,3,4-tetrahydronaphthalene 1-Hydroxy-7-Methoxy-1,2,3,4-tetrahydronaphthalene 32820-10-3 C11H14O2
BroMhexine Hydrochloride iMpurity DN-(2-AMino-5-broMobenzyl)-N-MethylcyclohexanaMine Dihydrochloride BroMhexine Hydrochloride iMpurity DN-(2-AMino-5-broMobenzyl)-N-MethylcyclohexanaMine Dihydrochloride 132004-28-5 C14H21BrN2
2-(DiMethylcarbaMoyl)benzoic acid, 97% 2-(DiMethylcarbaMoyl)benzoic acid, 97% 20320-37-0 C10H11NO3
RAC DESMETHYL CITALOPRAM HYDROCHLORIDE RAC DESMETHYL CITALOPRAM HYDROCHLORIDE 97743-99-2 C19H19FN2O
rac-3-Oxo Atorvastatin SodiuM Salt rac-3-Oxo Atorvastatin SodiuM Salt 1391052-00-8 C33H34FN2NaO5
2-Demethoxy-4-methoxy urapidil 2-Demethoxy-4-methoxy urapidil 34661-79-5 C20H29N5O3
Ribavirin IMpurity F Ribavirin IMpurity F 58151-87-4 C10H14N4O6
4-[-((-((4-(5-(Bis(2-hydroxyethyl)aMino)-1-Methyl-1H-benzo[d]iMidazol-2-yl)butanoyl)oxy)ethyl)(2-hydroxyethyl)aMino)-1-Methyl-1H-benzo[d]iMidazol-2-yl)butanic Acid 4-[-((-((4-(5-(Bis(2-hydroxyethyl)aMino)-1-Methyl-1H-benzo[d]iMidazol-2-yl)butanoyl)oxy)ethyl)(2-hydroxyethyl)aMino)-1-Methyl-1H-benzo[d]iMidazol-2-yl)butanic Acid 1228551-91-4 C32H41Cl3N6O4
3-(6,7-Dihydro-2-Methyl-7-oxo-3-propyl-2H-pyrazolo[4,3-d]pyriMidin-5-yl)-4-ethoxy-benzenesulfonyl Chloride 3-(6,7-Dihydro-2-Methyl-7-oxo-3-propyl-2H-pyrazolo[4,3-d]pyriMidin-5-yl)-4-ethoxy-benzenesulfonyl Chloride 501120-42-9 C17H19ClN4O4S
(3R,4S)-rel-3-[(1,3-Benzodioxol-5-yloxy)Methyl]-4-(4'-fluoro[1,1'-biphenyl]-4-yl)-piperidine Hydrochloride (3R,4S)-rel-3-[(1,3-Benzodioxol-5-yloxy)Methyl]-4-(4'-fluoro[1,1'-biphenyl]-4-yl)-piperidine Hydrochloride 1217655-87-2 C25H25ClFNO3
(16α)-16,17-[Butylidenebis(oxy)]-21-hydroxypregna-1,4-diene-3,11,20-trione (16α)-16,17-[Butylidenebis(oxy)]-21-hydroxypregna-1,4-diene-3,11,20-trione 216453-74-6 C25H32O6
6(S)-Hydroperoxy Simvastatin 6(S)-Hydroperoxy Simvastatin 149949-01-9 C25H38O7
Russupteridine IV Russupteridine IV 2535-20-8 C13H18N4O6
2-[(1-Benzylpiperidin-4-yl)hydroxyMethyl]-5,6-diMethoxyindan-1-one 2-[(1-Benzylpiperidin-4-yl)hydroxyMethyl]-5,6-diMethoxyindan-1-one 197010-20-1 C24H29NO4
5,6-trans-Ergocalciferol 5,6-trans-Ergocalciferol 51744-66-2 C28H44O
2-isonicotinoyl-5,6-diMethoxy-2,3-dihydro-1H-inden-1-one 2-isonicotinoyl-5,6-diMethoxy-2,3-dihydro-1H-inden-1-one 923571-15-7 C17H15NO4
4-(2-nitrophenyl)Morpholin-3-one 4-(2-nitrophenyl)Morpholin-3-one 845729-41-1 C10H10N2O4
2-Naphthalenecarboxylic acid, 4-hydroxy-8-Methyl- 2-Naphthalenecarboxylic acid, 4-hydroxy-8-Methyl- 16036-18-3 C12H10O3
Irbesartan IMpurity E Irbesartan IMpurity E C25H28N6O
LeflunoMide EP IMpurity G LeflunoMide EP IMpurity G 724429-16-7 C12H12N2O2
Telmisartan impurity C Telmisartan impurity C
Itraconazole iMpurity E Itraconazole iMpurity E
Edoxaban Isomer (RRR) Edoxaban Isomer (RRR) 1255529-24-8 C24H30ClN7O4S
1-NaphthaleneacetaMide, 1,2,3,4-tetrahydro-7-Methoxy- 1-NaphthaleneacetaMide, 1,2,3,4-tetrahydro-7-Methoxy- 92041-01-5 C13H17NO2
DO2A DO2A 112193-75-6 C12H24N4O4
Ruxolitinib Impurity 1 Ruxolitinib Impurity 1 3027185-21-0 C25H29N7
Flomoxef Impurity IV Flomoxef Impurity IV
Pitavastatin Impurity 54 Complete Set Pitavastatin Impurity 54 Complete Set
Cetrorelix Impurity 15 Cetrorelix Impurity 15
Brivaracetam Impurity 46 Brivaracetam Impurity 46
Atracurium Impurity H Complete Set Atracurium Impurity H Complete Set
Peramivir Intermediate Impurity 38 Peramivir Intermediate Impurity 38
Peramivir Guanidine Acetyl Positional Heterogeneous Impurities Peramivir Guanidine Acetyl Positional Heterogeneous Impurities
Ticagrelor impurity P drops Ticagrelor impurity P drops
Oxacillin sodium EP impurity J Oxacillin sodium EP impurity J
Piperacillin Sodium EP Impurity P Piperacillin Sodium EP Impurity P
(S)-N-(4-((3-chloro-4-fluorophenyl)amino)-7-((tetrahydrofuran-3-yl)oxy)quinazolin-6-yl)-4-(dimethylamino)butanamide (S)-N-(4-((3-chloro-4-fluorophenyl)amino)-7-((tetrahydrofuran-3-yl)oxy)quinazolin-6-yl)-4-(dimethylamino)butanamide
Ertapenem Impurity B(USP) Ertapenem Impurity B(USP)
INDEX NAME NOT YET ASSIGNED INDEX NAME NOT YET ASSIGNED 2458312-06-4 C27H30N2O6
15(R)-17-PHENYL TRINOR PROSTAGLANDIN F2ALPHA 15(R)-17-PHENYL TRINOR PROSTAGLANDIN F2ALPHA 41639-71-8 C23H32O5
(5R,6S)-6-((R)-1-hydroxyethyl)-3-((R)-tetrahydrofuran-2-yl)-4-thia-1-azabicyclo[3.2.0]hept-2-en-7-one (5R,6S)-6-((R)-1-hydroxyethyl)-3-((R)-tetrahydrofuran-2-yl)-4-thia-1-azabicyclo[3.2.0]hept-2-en-7-one
Acetamide, N-(4-hydroxyphenyl)-N-nitroso- Acetamide, N-(4-hydroxyphenyl)-N-nitroso- 146897-60-1 C8H8N2O3
RICE BRAN OIL RICE BRAN OIL 68553-81-1
3-Azetidineacetonitrile, 1-(ethylsulfonyl)-3-[4-(1H-pyrazol-4-yl)-7H-pyrrolo[2,3-d]pyrimidin-7-yl]- 3-Azetidineacetonitrile, 1-(ethylsulfonyl)-3-[4-(1H-pyrazol-4-yl)-7H-pyrrolo[2,3-d]pyrimidin-7-yl]- 2402776-83-2 C16H17N7O2S
Iohexol ImpuritiesE Iohexol ImpuritiesE
TERT-BUTYL (R)-6-CHLORO-5-HYDROXY-3-OXOHEXANOATE TERT-BUTYL (R)-6-CHLORO-5-HYDROXY-3-OXOHEXANOATE 404958-08-3 C10H17ClO4
2-(3-(4-(4-(1-(3-(cyanomethyl)-1-(ethylsulfonyl)azetidin-3-yl)-1H-pyrazol-4-yl)-7H-pyrrolo[2,3-d]pyrimidin-2-yl)-1H-pyrazol-1-yl)-1-(ethylsulfonyl)azetidin-3-yl)acetonitrile 2-(3-(4-(4-(1-(3-(cyanomethyl)-1-(ethylsulfonyl)azetidin-3-yl)-1H-pyrazol-4-yl)-7H-pyrrolo[2,3-d]pyrimidin-2-yl)-1H-pyrazol-1-yl)-1-(ethylsulfonyl)azetidin-3-yl)acetonitrile
8-chloro-11-(1-((5-methylpyridin-3-yl)methyl)piperidin-4-yl)-11H-benzo[5,6]cyclohepta[1,2-b]pyridine 8-chloro-11-(1-((5-methylpyridin-3-yl)methyl)piperidin-4-yl)-11H-benzo[5,6]cyclohepta[1,2-b]pyridine
	Bumetanide Photodegradable Impurity 16 Bumetanide Photodegradable Impurity 16
Bisoprolol Impurity 47 Bisoprolol Impurity 47
Gadobutrol Impurity 11(Ammonium salt) Gadobutrol Impurity 11(Ammonium salt)
Flomoxef Impurity F Flomoxef Impurity F
Tegoprazan Impurity 15 Tegoprazan Impurity 15
Nirmatrelvir Impurity 8 Nirmatrelvir Impurity 8
Nirmatrelvir Impurity 2 Nirmatrelvir Impurity 2
Roxadustat Impurity 17 Roxadustat Impurity 17
Perospirone Impurity 20 Perospirone Impurity 20 1002359-81-0
Dolutegravir Impurity 19 Dolutegravir Impurity 19
Cephalexin Impurity I Cephalexin Impurity I
Fondaparinux sodium impurity 6 Fondaparinux sodium impurity 6
	Fondaparinux sodium impurity 2 Fondaparinux sodium impurity 2
Oxacillin sodium  Impurity I Oxacillin sodium Impurity I
Mixture of Cefoxitin  Impurity E&F Mixture of Cefoxitin Impurity E&F
Revefenacin Impurity 22 Revefenacin Impurity 22
Lasmiditan Impurity 7 Lasmiditan Impurity 7
Febuxostat impurity BAC Febuxostat impurity BAC
4-(3,4-DICHLOROPHENYL)-1,2,3,4-TETRAHYDRO-1-NAPHTHALENOL 4-(3,4-DICHLOROPHENYL)-1,2,3,4-TETRAHYDRO-1-NAPHTHALENOL 866018-46-4 C16H14Cl2O
Letermovir Impurity 2 Letermovir Impurity 2
1H-Imidazole-2-carboxylic acid 1H-Imidazole-2-carboxylic acid 16042-25-4 C4H4N2O2
Olodaterol Impurity 19 Olodaterol Impurity 19
Ethacridine Impurity 12 Ethacridine Impurity 12
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