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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
Etoposide Impurity 2 Etoposide Impurity 2
Fludarabine EP impurity J Fludarabine EP impurity J
Ropivacaine Impurity 12 Ropivacaine Impurity 12
Solifenacin impurity 17 Solifenacin impurity 17 1029430-94-1 C19H17N3O
Sugammadex sodium Org205485-1 Impurity Sugammadex sodium Org205485-1 Impurity
Sugammadex sodium Org246653-1 Impurity Sugammadex sodium Org246653-1 Impurity
Tadalafil impurity R Tadalafil impurity R
N-((4-(5-(p-tolyl)-3-(trifluoromethyl)-1H-pyrazol-1-yl)phenyl) sulfonyl)acetamide N-((4-(5-(p-tolyl)-3-(trifluoromethyl)-1H-pyrazol-1-yl)phenyl) sulfonyl)acetamide 198471-47-5 C19H16F3N3O3S
Afatinib impurity 35 Afatinib impurity 35
Avibactam Impurity 40 Avibactam Impurity 40 2089462-89-3 C15H20N2O3
Butyphthalide impurity 29 Butyphthalide impurity 29
Butyphthalide impurity 38 Butyphthalide impurity 38 1841089-56-2 C24H30O5
Canagliflozin Impurity 39 Canagliflozin Impurity 39
Cefaclor double bond displacement impurity 9 Cefaclor double bond displacement impurity 9
Diquafosol Impurity 7 Diquafosol Impurity 7
Febuxostat Impurity 75 Febuxostat Impurity 75
Febuxostat Impurity 90 Febuxostat Impurity 90 2646683-37-4
Febuxostat Impurity 95 Febuxostat Impurity 95
(R)-De(trifluoromethyl) Fluoxetine Hydrochloride (R)-De(trifluoromethyl) Fluoxetine Hydrochloride 1212215-97-8 C16H20ClNO
CLOZAPINE-D3 CLOZAPINE-D3 1215691-72-7 C18H19ClN4
Bendamustine Impurity 25 Bendamustine Impurity 25
Canagliflozin Impurity 25 Canagliflozin Impurity 25
Edoxaban Impurity 41 Edoxaban Impurity 41 1353893-25-0 C14H27N3O3
Istradefylline Impurity 5 Istradefylline Impurity 5
Milrinone Impurity 10 Milrinone Impurity 10
N-(2-Chloro-ethyl)-N'-(2,3-dichloro-phenyl)-ethane-1,2-diamine N-(2-Chloro-ethyl)-N'-(2,3-dichloro-phenyl)-ethane-1,2-diamine C10H13Cl3N2
Olanzapine Impurity 3 Olanzapine Impurity 3 C17H20N4S
Ticagrelor Related Compound 54 Ticagrelor Related Compound 54
Adefovir Impurity D Adefovir Impurity D
Cefathiamidine Impurity 6 Cefathiamidine Impurity 6 28240-16-6 C12H13ClN2O6S
rac-2,2'-(((3aR,3a'R,4R,4'R,6S,6aS,6'S,6a'S)-((5-nitro-2-(propylthio)pyrimidine-4,6-diyl)bis(azanediyl))bis(2,2-dimethyltetrahydro-4H-cyclopenta[d][1,3]dioxole-6,4-diyl))bis(oxy))bis(ethan-1-ol) rac-2,2'-(((3aR,3a'R,4R,4'R,6S,6aS,6'S,6a'S)-((5-nitro-2-(propylthio)pyrimidine-4,6-diyl)bis(azanediyl))bis(2,2-dimethyltetrahydro-4H-cyclopenta[d][1,3]dioxole-6,4-diyl))bis(oxy))bis(ethan-1-ol) 1882095-50-2 C27H43N5O10S
Levofloxacin Impurity 23 Levofloxacin Impurity 23 2206825-95-6 C19H21ClFN3O4
Nitrendipine impurity 1 Nitrendipine impurity 1 1242511-98-3 C18H18N2O5
methyl 7-bromo-4-hydroxyisoquinoline-3-carboxylate methyl 7-bromo-4-hydroxyisoquinoline-3-carboxylate 1572439-66-7 C11H8BrNO3
Dapoxetine impurity Dapoxetine impurity 2242008-36-0 C28H26O3
Pregabalin Impurity 11 Pregabalin Impurity 11 177432-20-1 C7H11NO3
Pregabalin Impurity 6 Pregabalin Impurity 6 2102350-92-3 C9H15NO3
Sunitinib Impurity 2 Sunitinib Impurity 2
(2S,3R,4R,5S,6R)-2-(3-(4-ethoxybenzyl)phenyl)-6-(hydroxyl methyl)tetrahydro-2H-pyran-3,4,5-triol (2S,3R,4R,5S,6R)-2-(3-(4-ethoxybenzyl)phenyl)-6-(hydroxyl methyl)tetrahydro-2H-pyran-3,4,5-triol 2452300-89-7 C21H26O6
Fructus Xanthii Fructus Xanthii
(R)-Zanubrutinib (R)-Zanubrutinib 1691249-44-1 C27H29N5O3
LUMAT-005 LUMAT-005 313369-16-3 C16H19N3O3
Fimasartan Impurity F Fimasartan Impurity F
Ibrutinib Impurity 17 Ibrutinib Impurity 17 2134109-10-5 C16H18N6O
LCZ696(valsartan + sacubitril) impurity 36 LCZ696(valsartan + sacubitril) impurity 36
Lenvatinib Impurity 17 Lenvatinib Impurity 17
Moxifloxacin degradation impurity 36 Moxifloxacin degradation impurity 36
Moxifloxacin Impurity 49 Moxifloxacin Impurity 49
Olsalazine Impurity B Olsalazine Impurity B
Parecoxib sodium Impurity 32 Parecoxib sodium Impurity 32
Rosuvastatin Impurity 39 Rosuvastatin Impurity 39
Tofacitinib Impurity 95 Tofacitinib Impurity 95
Vildagliptin Impurity ZA4 Vildagliptin Impurity ZA4
(E)-4-(2-(1-(m-tolyl)ethylidene)hydrazinyl)benzenesulfonamide (E)-4-(2-(1-(m-tolyl)ethylidene)hydrazinyl)benzenesulfonamide C15H17N3O2S
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
1,2,4-Triazolo(3,4-b)benzothiazole-5-methanol 1,2,4-Triazolo(3,4-b)benzothiazole-5-methanol 69243-49-8 C9H7N3OS
Benzoicacid, 2-sulfino- Benzoicacid, 2-sulfino- 13165-80-5 C7H6O4S
Benzenemethanamine, a-ethyl-N,N-dimethyl- Benzenemethanamine, a-ethyl-N,N-dimethyl- 3330-05-0 C11H17N
CIS-1,2-BIS(AMINOMETHYL)CYCLOBUTANE CIS-1,2-BIS(AMINOMETHYL)CYCLOBUTANE 15286-88-1 C6H14N2
O-DesmethylApixabanSulphateNa O-DesmethylApixabanSulphateNa 1118765-14-2 C24H23N5O7S
4-Chloro-2-fluoro-N-methylbenzamide 4-Chloro-2-fluoro-N-methylbenzamide 1343038-33-4 C8H7ClFNO
N-FORMYL-1-(2-AMINO-1-(4-METHOXYPHENYL)ETHYL)CYCLOHEXANOL N-FORMYL-1-(2-AMINO-1-(4-METHOXYPHENYL)ETHYL)CYCLOHEXANOL 272788-07-5 C16H23NO3
2-(7-methoxy-3,4-dihydronaphthalen-1-yl)ethan-1-amine 2-(7-methoxy-3,4-dihydronaphthalen-1-yl)ethan-1-amine 1353100-18-1 C13H18ClNO
Acotiamide  Impurity Acotiamide Impurity 198470-83-6 C20H21N2NaO4S
Terbutaline  Impurity Terbutaline Impurity 52144-90-8 C26H29NO3
methyl (41S,12R,13aR)-13a-ethyl-12-
hydroxy-2,3,41,5,6,12,13,13aoctahydro-
1H-indolo[3,2,1-
de]pyrido[3,2,1-ij][1,5]naphthyridine-
12-carboxylate methyl (41S,12R,13aR)-13a-ethyl-12- hydroxy-2,3,41,5,6,12,13,13aoctahydro- 1H-indolo[3,2,1- de]pyrido[3,2,1-ij][1,5]naphthyridine- 12-carboxylate 83508-83-2 C21H26N2O3
ethyl 4-(5-methyl-3-phenylisoxazol-4-yl)benzenesulfonate ethyl 4-(5-methyl-3-phenylisoxazol-4-yl)benzenesulfonate 473465-11-1 C18H18N2O3S
Ropivacaine-iPr-R Ropivacaine-iPr-R 1050482-18-2 C17H26N2O
Demiditraz IMpurity Demiditraz IMpurity 944268-66-0 C20H22N2O
AcarBose EP Impurity B AcarBose EP Impurity B 1220983-54-9 C26H43NO17
Alogliptin Impurity 17 Alogliptin Impurity 17
Aprepitant Impurity 15 Aprepitant Impurity 15 1447693-83-5 C20H19ClF7NO2
Ethylmethyl-carbamic chloride Ethylmethyl-carbamic chloride 42252-34-6 C4H8ClNO
N-(3-{[(4-methylphenyl)sulfonyl]amino}phenyl)acetamide N-(3-{[(4-methylphenyl)sulfonyl]amino}phenyl)acetamide 329941-39-1 C15H16N2O3S
Cisatracurium-20-methyl Dibenzenesulfonate Cisatracurium-20-methyl Dibenzenesulfonate 1193104-85-6 C60H79N2O15S+
[R-(R*,S*)]-(-)-N-(1-PHENYLETHYL)-1-AZABICYCLO[2.2.2]OCTAN-3-AMINE DIHYDROCHLORIDE [R-(R*,S*)]-(-)-N-(1-PHENYLETHYL)-1-AZABICYCLO[2.2.2]OCTAN-3-AMINE DIHYDROCHLORIDE 128311-06-8 C15H24Cl2N2
GURKHSYORGJETM-MGDILKBHSA-N GURKHSYORGJETM-MGDILKBHSA-N 1992961-26-8 C33H39ClN4O6
Despropoxy Ethoxy Udenafil Despropoxy Ethoxy Udenafil 268204-07-5 C24H34N6O4S
DVCUGHHGLKCBMT-QVDQXJPCSA-N DVCUGHHGLKCBMT-QVDQXJPCSA-N 1356353-76-8 C15H24N6O6
5,6-Dehydro-Tigecycline 5,6-Dehydro-Tigecycline 1633815-62-9 C29H37N5O8
2,3,5,6-tetradeuterio-4-[5-[4-(hydroxymethyl)phenyl]-3-(trifluoromethyl)pyrazol-1-yl]benzenesulfonamide 2,3,5,6-tetradeuterio-4-[5-[4-(hydroxymethyl)phenyl]-3-(trifluoromethyl)pyrazol-1-yl]benzenesulfonamide 1276524-56-1 C17H10D4F3N3O3S
1,1-diphenylpropan-1-ol 1,1-diphenylpropan-1-ol 5180-33-6 C15H16O
(1R,5S)-1-phenyl-3-oxabicyclo[3.1.0]hexan-2-one (1R,5S)-1-phenyl-3-oxabicyclo[3.1.0]hexan-2-one 96847-52-8 C11H10O2
(1R,1'R,2S,2'S)-2,2'-[1,5-pentanediylbis[oxy(3-oxo-3,1-propanediyl)]]bis[1-[(3,4-dimethoxyphenyl)methyl]-1,2,3,4-tetrahydro-6,7-dimethoxy-2-methyl-Isoquinolinium Benzenesulfonate (1R,1'R,2S,2'S)-2,2'-[1,5-pentanediylbis[oxy(3-oxo-3,1-propanediyl)]]bis[1-[(3,4-dimethoxyphenyl)methyl]-1,2,3,4-tetrahydro-6,7-dimethoxy-2-methyl-Isoquinolinium Benzenesulfonate 96946-46-2 C59H77N2O15S+
(2R,3R,4R,5R)-2-(4-amino-2-oxo-1,3,5-triazin-1(2H)-yl)-4-hydroxy-5-(hydroxymethyl)tetrahydrofuran-3-yl acetate (2R,3R,4R,5R)-2-(4-amino-2-oxo-1,3,5-triazin-1(2H)-yl)-4-hydroxy-5-(hydroxymethyl)tetrahydrofuran-3-yl acetate C10H14N4O6
12-ethyl-8-methyl-9-oxo-7-propionyl-9,11-dihydroindolizino[1,2-b]quinolin-2-yl [1,4'-bipiperidine]-1'-carboxylate 12-ethyl-8-methyl-9-oxo-7-propionyl-9,11-dihydroindolizino[1,2-b]quinolin-2-yl [1,4'-bipiperidine]-1'-carboxylate 176515-52-9 C32H38N4O4
4-amino-5-chloro-N-(1-propylpiperidin-4-yl)-2,3-dihydrobenzofuran-7-carboxamide 4-amino-5-chloro-N-(1-propylpiperidin-4-yl)-2,3-dihydrobenzofuran-7-carboxamide C17H24ClN3O2
Ceftazidime Impurity D Ceftazidime Impurity D
Ceftazidime Sulfoxide Impurity Ceftazidime Sulfoxide Impurity
Tofacitinib Impurity Y Tofacitinib Impurity Y
5-amino-6-chloro-2-(propylthio)pyrimidin-4-ol 5-amino-6-chloro-2-(propylthio)pyrimidin-4-ol C7H10ClN3OS
Labetalol EP impurity G Labetalol EP impurity G
2-(2-NITROPHENYL)ETHANAMINE 2-(2-NITROPHENYL)ETHANAMINE 33100-15-1 C8H10N2O2
Blonanserin Impurity N Blonanserin Impurity N
Brexpiprazole Impurity N Brexpiprazole Impurity N
Cefaclor Impurity 1 Cefaclor Impurity 1
Cefminox Sodium impurity 4 Cefminox Sodium impurity 4
Cefradine Impurity B Cefradine Impurity B
Dapoxetine Impurity F Dapoxetine Impurity F
Olaparib Impurity E Olaparib Impurity E
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