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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
ethyl(4aS,9bR)-6-bromo-1,3,4,4a,5,9b-hexahydro-2H-pyrido[4,3-b]indole-2-carboxylate ethyl(4aS,9bR)-6-bromo-1,3,4,4a,5,9b-hexahydro-2H-pyrido[4,3-b]indole-2-carboxylate 1059630-08-8 C14H17BrN2O2
diphenhydramine impurity diphenhydramine impurity C17H21NO
Pyridine, 4-chloro-2-(chloromethyl)-3,5-dimethyl-, hydrochloride Pyridine, 4-chloro-2-(chloromethyl)-3,5-dimethyl-, hydrochloride 143016-68-6 C8H10Cl3N
1,1-dimethyl-4-(2-methyl-10H-benzo[b]thieno[2,3-e][1,4]diazepin-4-yl)piperazin-1-ium iodide 1,1-dimethyl-4-(2-methyl-10H-benzo[b]thieno[2,3-e][1,4]diazepin-4-yl)piperazin-1-ium iodide C18H23IN4S
2-(4-butoxy-3-cyanophenyl)-4-methylthiazole-5-carboxylic acid 2-(4-butoxy-3-cyanophenyl)-4-methylthiazole-5-carboxylic acid 1657014-33-9 C16H16N2O3S
vildagliptin Impurity O vildagliptin Impurity O 2253194-12-4 C12H18N4O2
methyl (41R,12S,13aR)-13a-ethyl-12-hydroxy-2,3,41,5,6,12,13,13a-octahydro-1H-indolo[3,2,1-de]pyrido[3,2,1-ij][1,5]naphthyridine-12-carboxylate methyl (41R,12S,13aR)-13a-ethyl-12-hydroxy-2,3,41,5,6,12,13,13a-octahydro-1H-indolo[3,2,1-de]pyrido[3,2,1-ij][1,5]naphthyridine-12-carboxylate 38990-17-9 C21H26N2O3
1-(3-ethoxy-4-methoxyphenyl)-2-(methylsulfonyl)ethenamine 1-(3-ethoxy-4-methoxyphenyl)-2-(methylsulfonyl)ethenamine 1450657-31-4 C12H17NO4S
Apremilast Impurity D Apremilast Impurity D
Canagliflozin Impurity 17 Canagliflozin Impurity 17 1951467-28-9 C24H23FO6S
Canagliflozin Impurity 22 Canagliflozin Impurity 22
Carfilzomib Impurity 3 Carfilzomib Impurity 3
Dolutegravir Impurity 4 Dolutegravir Impurity 4
Febuxostat Impurity 20 Febuxostat Impurity 20
Lenvatinib Impurity 1 Lenvatinib Impurity 1
methyl (41S,12S,13aR)-13a-ethyl-12-hydroxy-2,3,41,5,6,12,13,13a-octahydro-1H-indolo[3,2,1-de]pyrido[3,2,1-ij][1,5]naphthyridine-12-carboxylate methyl (41S,12S,13aR)-13a-ethyl-12-hydroxy-2,3,41,5,6,12,13,13a-octahydro-1H-indolo[3,2,1-de]pyrido[3,2,1-ij][1,5]naphthyridine-12-carboxylate 83508-82-1 C21H26N2O3
4-[6-[(8-cyclopentyl-6-ethenyl-7,8-dihydro-5-methyl-7-oxopyrido[2,3-d]pyrimidin-2-yl)amino]-3-pyridinyl]-1-piperazinecarboxylic acid tert-butyl ester 4-[6-[(8-cyclopentyl-6-ethenyl-7,8-dihydro-5-methyl-7-oxopyrido[2,3-d]pyrimidin-2-yl)amino]-3-pyridinyl]-1-piperazinecarboxylic acid tert-butyl ester 1941177-45-2 C29H37N7O3
Cabozantinib impurity 1 Cabozantinib impurity 1 748707-58-6 C17H16N2O3
1,2-Cyclopropanedimethanol, 1-(3-fluorophenyl)-, 1,2-diacetate, (1S,2R)- 1,2-Cyclopropanedimethanol, 1-(3-fluorophenyl)-, 1,2-diacetate, (1S,2R)- 1369768-30-8 C15H17FO4
4-[(2,3-Dihydro-5,6-dimethoxy-1H-inden-2-yl)methyl]-1-(phenylmethyl)piperidine Hydrochloride 4-[(2,3-Dihydro-5,6-dimethoxy-1H-inden-2-yl)methyl]-1-(phenylmethyl)piperidine Hydrochloride 1034439-57-0 C24H32ClNO2
5-(aminosulfonyl)-2-methoxybenzamide 5-(aminosulfonyl)-2-methoxybenzamide 52395-25-2 C8H10N2O4S
PIPERIDINE-3-CARBOXYLIC ACID (2,6-DIMETHYL-PHENYL)-AMIDE PIPERIDINE-3-CARBOXYLIC ACID (2,6-DIMETHYL-PHENYL)-AMIDE 337488-90-1 C14H20N2O
N-Desmethyl Citalopram-d4 Oxalate N-Desmethyl Citalopram-d4 Oxalate 62498-68-4 C21H21FN2O5
2-Ethoxy-6-nitro-9-acridinamine 2-Ethoxy-6-nitro-9-acridinamine 20304-70-5 C15H13N3O3
4-O-Carboxymethyl-21-deoxy-20-hydroxy-21-oxorifamycin 4-O-Carboxymethyl-21-deoxy-20-hydroxy-21-oxorifamycin 15271-73-5 C39H47NO15
(3,4-Dimethoxyphenyl)isopropyl ketone (3,4-Dimethoxyphenyl)isopropyl ketone 14046-55-0 C12H16O3
2,3-Dichloro-5,6-diphenylpyrazine 2,3-Dichloro-5,6-diphenylpyrazine 57038-62-7 C16H10Cl2N2
DIDESMETHYL CITALOPRAM-D4 DIDESMETHYL CITALOPRAM-D4 62498-69-5 C18H17FN2O
Bis(3-hydroxypropyl) persulfide Bis(3-hydroxypropyl) persulfide 30453-21-5 C6H14O2S2
CHLOROAC-PRO-OH CHLOROAC-PRO-OH 23500-10-9 C7H10ClNO3
2,4-Dihydro-4-[4-[4-(4-methoxyphenyl)-1-piperazinyl]phenyl]-2-(1-methylpropyl)-3H-1,2,4-triazol-3-one 2,4-Dihydro-4-[4-[4-(4-methoxyphenyl)-1-piperazinyl]phenyl]-2-(1-methylpropyl)-3H-1,2,4-triazol-3-one 252964-68-4 C23H29N5O2
2-(2-Methoxyphenoxy)ethanol 2-(2-Methoxyphenoxy)ethanol 18181-71-0 C9H12O3
2-(3-Chloro-2-hydroxypropyl)-2H-isoindole-1,3-dione 2-(3-Chloro-2-hydroxypropyl)-2H-isoindole-1,3-dione 19667-37-9 C11H10ClNO3
4,6-Dibromo-m-cresol 4,6-Dibromo-m-cresol 13321-76-1 C7H6Br2O
(R)-2,4-Dihydroxy-3,3-dimethylbutyric acid sodium salt (R)-2,4-Dihydroxy-3,3-dimethylbutyric acid sodium salt 60979-68-2 C{6}H{11}NaO{4}
Maribavir (CAS:176161-24-3) Maribavir (CAS:176161-24-3)
Amlodipine Impurity 19 Amlodipine Impurity 19 C26H31ClN2O8S
Amlodipine Impurity 9 Amlodipine Impurity 9 90445-05-9 C26H31ClN2O8S
Clopidogrel Impurity 7 Clopidogrel Impurity 7 444728-13-6 C15H15ClN2OS
Rivaroxaban Impurity 36 Rivaroxaban Impurity 36 1770812-39-9 C19H17Cl2N3O5S
(S)-methyl 2-((2'-(2H-tetrazol-5-yl)biphenyl-4-yl)methylamino)-3-methylbutanoate (S)-methyl 2-((2'-(2H-tetrazol-5-yl)biphenyl-4-yl)methylamino)-3-methylbutanoate 1111177-24-2 C20H23N5O2
Clopidogrel Impurity C Clopidogrel Impurity C 1346605-15-9 C16H18ClNO2S
Nilotinib genotoxic impurity 2 Nilotinib genotoxic impurity 2 1157857-29-8 C19H15F3N4O3
NCFJJNFEEPMRAQ-XMMPIXPASA-N NCFJJNFEEPMRAQ-XMMPIXPASA-N 1453221-45-8 C35H41F6N3O6
Gliclazide Impurity E Gliclazide Impurity E
Ethyl 1-butanesulfonate Ethyl 1-butanesulfonate 2374-68-7 C6H14O3S
OLANEXIDINE intermediate OLANEXIDINE intermediate 60852-95-1 C10H20N4
1H-Isoindole, octahydro-, trans- 1H-Isoindole, octahydro-, trans- 10479-63-7 C8H15N
1H-Purine-2,6-dione,8-[2-(3,4-dihydroxyphenyl)ethenyl]-1,3-diethyl-3,7-dihydro-7-methyl-, (E)-(9CI) 1H-Purine-2,6-dione,8-[2-(3,4-dihydroxyphenyl)ethenyl]-1,3-diethyl-3,7-dihydro-7-methyl-, (E)-(9CI) 155272-03-0 C18H20N4O4
Hexanoicacid, 3-(2-amino-2-oxoethyl)-5-methyl-, (3S)- Hexanoicacid, 3-(2-amino-2-oxoethyl)-5-methyl-, (3S)- 181289-34-9 C9H17NO3
Ethanedioic acid, monoethyl ester, 2-(4-methoxyphenyl)hydrazide Ethanedioic acid, monoethyl ester, 2-(4-methoxyphenyl)hydrazide 2614-10-0 C11H14N2O4
4-Pyridinecarboxamide, N-[2-(nitrooxy)ethyl]-, mononitrate 4-Pyridinecarboxamide, N-[2-(nitrooxy)ethyl]-, mononitrate 65141-48-2 C8H10N4O7
1-[3,4-dihydroxy-5-(hydroxymethyl)oxolan-2-yl]-5-hydroxy-pyrimidine-2,4-dione 1-[3,4-dihydroxy-5-(hydroxymethyl)oxolan-2-yl]-5-hydroxy-pyrimidine-2,4-dione 69321-95-5 C9H12N2O7
2-(ACETOXYMETHYL)-4-METHOXY-3,5-DIMETHYLPYRIDINE 2-(ACETOXYMETHYL)-4-METHOXY-3,5-DIMETHYLPYRIDINE 91219-90-8 C11H15NO3
2-[(5-CARBOXY-4-METHOXY-3-METHYLPYRID-2-YL)-METHYLSULFO]-5-METHOXYBENZIMIDAZOLE 2-[(5-CARBOXY-4-METHOXY-3-METHYLPYRID-2-YL)-METHYLSULFO]-5-METHOXYBENZIMIDAZOLE 120003-72-7 C17H17N3O5S
3-(7,8-dimethoxy-2-oxo-1,2,4,5-tetrahydro-3H-benzo[d]azepin-3-yl)-N-(((S)-3,4-dimethoxybicyclo[4.2.0]octa-1(6),2,4-trien-7-yl)methyl)-N-methylpropan-1-amine oxide 3-(7,8-dimethoxy-2-oxo-1,2,4,5-tetrahydro-3H-benzo[d]azepin-3-yl)-N-(((S)-3,4-dimethoxybicyclo[4.2.0]octa-1(6),2,4-trien-7-yl)methyl)-N-methylpropan-1-amine oxide 2511244-97-4 C27H36N2O6
2,4,6,3',5'-pentamethoxybiphenyl 2,4,6,3',5'-pentamethoxybiphenyl 84212-55-5 C17H20O5
2-benzoyl-N-(2-hydroxyethyl)-N-methylbenzamide 2-benzoyl-N-(2-hydroxyethyl)-N-methylbenzamide 24833-47-4 C17H17NO3
Labetalol EP Impurity I Labetalol EP Impurity I
(Asp4)-Carbetocin (Impurity G) (Asp4)-Carbetocin (Impurity G)
Sulfamide, N-[5-(4-bromophenyl)-6-[2-[(5-chloro-2-pyrimidinyl)oxy]ethoxy]-4-pyrimidinyl]-N'-propyl- Sulfamide, N-[5-(4-bromophenyl)-6-[2-[(5-chloro-2-pyrimidinyl)oxy]ethoxy]-4-pyrimidinyl]-N'-propyl- 2443747-63-3 C19H20BrClN6O4S
methyl 3-oxo1,2-benzisothiazole-2(3H)-acetate 1,1-dioxide methyl 3-oxo1,2-benzisothiazole-2(3H)-acetate 1,1-dioxide 6639-62-9 C10H9NO5S
(6R-cis)-3-(hydroxymethyl)-7-methoxy-8-oxo-7-(2-thienylacetamido)-5-thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylic acid (6R-cis)-3-(hydroxymethyl)-7-methoxy-8-oxo-7-(2-thienylacetamido)-5-thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylic acid 54333-94-7 C15H16N2O6S2
5-acetyl-1,3-phenylene bis(dimethylcarbamate) 5-acetyl-1,3-phenylene bis(dimethylcarbamate) 81732-48-1 C14H18N2O5
Oseltamivir  Impurity L Oseltamivir Impurity L
1,4-Naphthalenediol, 2-methyl-, 4-acetate 1,4-Naphthalenediol, 2-methyl-, 4-acetate 110327-29-2 C13H12O3
2-amino-4-(2-(benzyl(1-(4-methoxyphenyl)propan-2-yl)amino)-1-hydroxyethyl)phenol 2-amino-4-(2-(benzyl(1-(4-methoxyphenyl)propan-2-yl)amino)-1-hydroxyethyl)phenol
Peramivir Deacetyl Impurity Peramivir Deacetyl Impurity
Empagliflozin Impurity 116 Empagliflozin Impurity 116
(3R,5aS)-5,8-dioxooctahydro-5H-pyrrolo[1,2-a]thiazolo[3,2-d]pyrazine-3-carboxylic acid (3R,5aS)-5,8-dioxooctahydro-5H-pyrrolo[1,2-a]thiazolo[3,2-d]pyrazine-3-carboxylic acid
Phospholipid Impurity 1(DPPE-MPEG5000 Impurity 1) Phospholipid Impurity 1(DPPE-MPEG5000 Impurity 1)
Carbazochrome Sodium Sulfonate Impurity 4 Carbazochrome Sodium Sulfonate Impurity 4
Empagliflozin Furanose Impurity Empagliflozin Furanose Impurity
Rosuvastatin Impurity 144 Rosuvastatin Impurity 144
Cetrorelix Impurity 11 Cetrorelix Impurity 11
Cetrorelix Impurity 4 (8-D-Arg) Cetrorelix Impurity 4 (8-D-Arg)
DMT-2'-O-4'-C-Locked-G(iBu)-CE DMT-2'-O-4'-C-Locked-G(iBu)-CE
ALS 8123 ALS 8123 81148-15-4 C15H23NO4
Ro 14-7437 Ro 14-7437 78756-03-3 C15H15N3O3
4-(2-Cyanophenyl)benzaldehyde 4-(2-Cyanophenyl)benzaldehyde 135689-93-9 C14H9NO
2-(N,N-DIETHYLAMINO)-4,6-DICHLOROTRIAZINE 2-(N,N-DIETHYLAMINO)-4,6-DICHLOROTRIAZINE 2401-64-1 C5H6Cl2N4
(S)-4-Chloro-1,3-butanediol (S)-4-Chloro-1,3-butanediol 139013-68-6 C4H9ClO2
6-CHLORO-1-METHYLURACIL 6-CHLORO-1-METHYLURACIL 31737-09-4 C5H5ClN2O2
5-(Propylthio)-1H-benzimidazol-2-amine 5-(Propylthio)-1H-benzimidazol-2-amine 80983-36-4 C10H13N3S
Ethyl 4,5-bis(2-methoxyethoxy)-2-nitrobenzoate Ethyl 4,5-bis(2-methoxyethoxy)-2-nitrobenzoate 179688-26-7 C15H21NO8
Hexyl methanesulfonate Hexyl methanesulfonate 16156-50-6 C7H16O3S
5-CHLOROTHIOPHENE-3-CARBOXYLIC ACID 5-CHLOROTHIOPHENE-3-CARBOXYLIC ACID 36157-42-3 C5H3ClO2S
(S)-(+)-1-[(4-Chlorophenyl)phenylmethyl]piperazine (S)-(+)-1-[(4-Chlorophenyl)phenylmethyl]piperazine 439858-21-6 C17H19ClN2
2,8-Dichloro-5,6-dihydro-11H-benzo[5,6]cyclohepta[1,2-β]pyridin-11-one 2,8-Dichloro-5,6-dihydro-11H-benzo[5,6]cyclohepta[1,2-β]pyridin-11-one 133330-61-7 C14H9Cl2NO
2-Isopropyl-6-propylphenol (Propofol Impurity O) 2-Isopropyl-6-propylphenol (Propofol Impurity O) 74663-48-2 C12H18O
3-Methyl-2-(3,4-dimethoxyphenyl)butyronitrile 3-Methyl-2-(3,4-dimethoxyphenyl)butyronitrile 20850-49-1 C13H17NO2
HYDROXY ITRACONAZOLE HYDROXY ITRACONAZOLE 112559-91-8 C35H38Cl2N8O5
N-nitroso-levomethoate 1 N-nitroso-levomethoate 1
1-HEXADECANOYL-2-(P-NITROPHENOXYSUCCINOYL)-SN-GLYCERYL-3-PHOSPHORYLCHOLINE 1-HEXADECANOYL-2-(P-NITROPHENOXYSUCCINOYL)-SN-GLYCERYL-3-PHOSPHORYLCHOLINE 170569-87-6 C16H12F3N3O2S
N-methyl-N-(4-nitrophenyl)-2-(piperazin-1-yl)acetamide N-methyl-N-(4-nitrophenyl)-2-(piperazin-1-yl)acetamide 1038972-16-5 C13H18N4O3
1,4-BIS[3,4-DIHYDRO-2(1H)-QUINOLINON-7-OXY]BUTANE 1,4-BIS[3,4-DIHYDRO-2(1H)-QUINOLINON-7-OXY]BUTANE 882880-12-8 C22H24N2O4
(R)-SN-38 (R)-SN-38 647852-82-2 C22H20N2O5
5'-Deoxy-5-fluoro-N4-(isopentyloxycarbonyl)cytidine 5'-Deoxy-5-fluoro-N4-(isopentyloxycarbonyl)cytidine 162204-30-0 C15H22FN3O6
4'-((2-butyl-4-oxo-1,3-diazaspiro[4.4]non-1-en-3-yl)methyl)-N-(4,5-dimethylisoxazol-3-yl)-2'-(ethoxymethyl)-[1,1'-biphenyl]-4-sulfonamide 4'-((2-butyl-4-oxo-1,3-diazaspiro[4.4]non-1-en-3-yl)methyl)-N-(4,5-dimethylisoxazol-3-yl)-2'-(ethoxymethyl)-[1,1'-biphenyl]-4-sulfonamide
(2S,3R,4R,5S,6R)-2-(4-bromo-3-(4-ethoxybenzyl)phenyl)-6-(methylthio)tetrahydro-2H-pyran-3,4,5-triol (2S,3R,4R,5S,6R)-2-(4-bromo-3-(4-ethoxybenzyl)phenyl)-6-(methylthio)tetrahydro-2H-pyran-3,4,5-triol
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