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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
Rotigotine Impurity 2 Rotigotine Impurity 2
Rotigotine Impurity 9 Rotigotine Impurity 9
Olprinone Impurity 5 Olprinone Impurity 5
Vitamin B5 Impurity 1 Vitamin B5 Impurity 1 897045-90-8 C12H22N2O6
Cilastatin Impurity 5 Cilastatin Impurity 5
(R)-3-(4-(2-chloro-5-iodobenzyl)phenoxy)tetrahydrofuran (R)-3-(4-(2-chloro-5-iodobenzyl)phenoxy)tetrahydrofuran 2194590-02-6 C17H16ClIO2
Sitagliptin Impurity 69 Sitagliptin Impurity 69 2172430-88-3 C15H16F3NO4
Dimethyl (1-Diazo-2-oxopropyl)phosphonate Dimethyl (1-Diazo-2-oxopropyl)phosphonate 90965-06-3 C5H9N2O4P
Trimetazidine Impurity 8 Trimetazidine Impurity 8
MeropeneM iMpurity 5 MeropeneM iMpurity 5
Perindopril IMpurity 6 Perindopril IMpurity 6 2163775-15-1 C8H15NO4
Oseltamivir Impurity 48 Oseltamivir Impurity 48 651324-04-8 C18H33NO4
Tamsulosin impurity 5 Tamsulosin impurity 5 C20H28N2O5S
Flucloxacillin Impurity 5 Flucloxacillin Impurity 5
Nitrendipine iMpurity G Nitrendipine iMpurity G
(S)-N-(5-((S)-2-(2,5-difluorophenyl)pyrrolidin-1-yl)pyrazolo[1,5-a]pyrimidin-3-yl)-3-hydroxypyrrolidine-1-carboxamide (S)-N-(5-((S)-2-(2,5-difluorophenyl)pyrrolidin-1-yl)pyrazolo[1,5-a]pyrimidin-3-yl)-3-hydroxypyrrolidine-1-carboxamide 2409589-59-7 C21H22F2N6O2
Afatinib Impurity 53 Afatinib Impurity 53
Afatinib Impurity 68 Afatinib Impurity 68
(S)-N-(1-(3-MethylbutanaMido)-1-oxo-3-phenylpropan-2-yl)pyrazine-2-carboxaMide (S)-N-(1-(3-MethylbutanaMido)-1-oxo-3-phenylpropan-2-yl)pyrazine-2-carboxaMide 862894-96-0 C19H22N4O3
Ticagrelor iMpurity Ticagrelor iMpurity 1882095-51-3 C27H45N5O8S
cefaclor iMpurity G cefaclor iMpurity G 67308-21-8 C16H17N3O4S
Rupatadine iMpurity E Rupatadine iMpurity E
Tadalafil iMpurity D Tadalafil iMpurity D 951661-81-7 C22H20ClN3O4
Alogliptin Impurity 26 Alogliptin Impurity 26
Empagliflozin Impurity 61 Empagliflozin Impurity 61
Ipragliflozin Impurity 3 Ipragliflozin Impurity 3 1922933-61-6 C21H21FO6S
Isavuconazole Impurity 30 Isavuconazole Impurity 30
Levetiracetam Impurity 27 Levetiracetam Impurity 27
Linagliptin Impurity 58 Linagliptin Impurity 58
Oseltamivir Impurity 33 Oseltamivir Impurity 33
Oseltamivir Impurity 49 Oseltamivir Impurity 49
Palbociclib Impurity 52 Palbociclib Impurity 52
Palbociclib Impurity 37 Palbociclib Impurity 37
Pazufloxacin Impurity 16 Pazufloxacin Impurity 16 165071-10-3 C14H10FNO6
Pimecrolimus Impurity 4 Pimecrolimus Impurity 4
Posaconazole Impurity 73 Posaconazole Impurity 73
Rosuvastatin Impurity 90 Rosuvastatin Impurity 90 2226413-62-1 C38H44F2N6O8S2
Tofacitinib Impurity 110 Tofacitinib Impurity 110
Tofacitinib Impurity 115 Tofacitinib Impurity 115
Trelagliptin Impurity 27 Trelagliptin Impurity 27
Vildagliptin Impurity 30 Vildagliptin Impurity 30 918830-94-1 C10H17NO2
N-methyl-N-((3R,4R)-4-methylpiperidin-3-yl)-7H-pyrrolo[2,3-d] pyrimidin-2-amine N-methyl-N-((3R,4R)-4-methylpiperidin-3-yl)-7H-pyrrolo[2,3-d] pyrimidin-2-amine C13H19N5
Tolvaptan Impurity 6 Tolvaptan Impurity 6 1432725-24-0 C18H19ClN2O2
Esmolol impurity B Esmolol impurity B
Esmolol impurity F Esmolol impurity F
Diquafosol Impurity E Diquafosol Impurity E
Bortezomib Impurity 39 Bortezomib Impurity 39
Agomelatine Impurity 1 Agomelatine Impurity 1
Sunitinib Impurity 5 Sunitinib Impurity 5
Silodosin Impurity 6 Silodosin Impurity 6
Erlotinib Impurity 19 Erlotinib Impurity 19
Ticagrelor Impurity 40 Ticagrelor Impurity 40
Moxifloxacin Impurity 12 Moxifloxacin Impurity 12
Cabozantinib Impurity 4 Cabozantinib Impurity 4
N1-Methylbenzene-1,2,4-triaMine N1-Methylbenzene-1,2,4-triaMine 60651-29-8 C7H11N3
RocuroniuMbroMide iMpurity H RocuroniuMbroMide iMpurity H
1-[(2'-carbaMoylbiphenyl-4-yl) Methyl]-2-ethoxybenziMidazole-7-carboxylic acid 1-[(2'-carbaMoylbiphenyl-4-yl) Methyl]-2-ethoxybenziMidazole-7-carboxylic acid 1696392-11-6 C24H21N3O4
5-chloro-1-(3-diMethylaMinopropyl)-1-(4-fluorophenyl)-phthalan 5-chloro-1-(3-diMethylaMinopropyl)-1-(4-fluorophenyl)-phthalan 64169-45-5 C19H21ClFNO
dextroMethorphanone dextroMethorphanone
oxiracetaM related substance ISF3886 oxiracetaM related substance ISF3886 120428-80-0 C8H13N3O4
Carvedilol IMpurity D Carvedilol IMpurity D 1391052-16-6 C39H39N3O6
DL-2-(4-Carboxyphenyl)propionic Acid DL-2-(4-Carboxyphenyl)propionic Acid 67381-50-4 C10H10O4
Betamethasone 17-Propionate 21-Mesylate Betamethasone 17-Propionate 21-Mesylate 15423-80-0 C26H35FO8S
ClarithroMycin EP IMpurity F ClarithroMycin EP IMpurity F 128940-83-0 C39H71NO13
3(R)-Hydroperoxy Simvastatin 3(R)-Hydroperoxy Simvastatin 1092716-42-1 C25H38O7
Albendazole EP IMpurity F Albendazole EP IMpurity F 80983-45-5 C10H11N3O2S
10-Dehydrobaccatin V 10-Dehydrobaccatin V 151636-94-1 C29H34O10
DoxylaMine EP IMpurity A DoxylaMine EP IMpurity A 873407-01-3 C17H22N2O
((1R,3R,E)-5-((E)-2-((1R,3aS,7aR)-1-((2R,5R,E)-5,6-diMethylhept-3-en-2-yl)-7a-Methyldihydro-1H-inden-4(2H,5H,6H,7H,7aH)-ylidene)ethylidene)-4-Methylenecyclohexane-1,3-diyl)bis(oxy)bis(tert-butyldiMethylsilane) ((1R,3R,E)-5-((E)-2-((1R,3aS,7aR)-1-((2R,5R,E)-5,6-diMethylhept-3-en-2-yl)-7a-Methyldihydro-1H-inden-4(2H,5H,6H,7H,7aH)-ylidene)ethylidene)-4-Methylenecyclohexane-1,3-diyl)bis(oxy)bis(tert-butyldiMethylsilane) 115540-28-8 C40H72O2Si2
Clopidogrel EP IMpurity D Clopidogrel EP IMpurity D 1421283-60-4 C24H21Cl2NO4S
Loratadine IMpurity E Loratadine IMpurity E C22H23ClN2O2
Metoprolol IMpurity E Metoprolol IMpurity E C15H25NO3
IMp. A (EP): 4-Methyl-6-(1-Methyl-1H-benziMidazol-2-yl)-2-propyl-1H-benziMidazole IMp. A (EP): 4-Methyl-6-(1-Methyl-1H-benziMidazol-2-yl)-2-propyl-1H-benziMidazole
(2S,4S)-4-[4-(3-Methyl-1-phenyl-1H-pyrazol-5-yl)-1-piperazinyl]-2-(3-thiazolidinylcarbonyl)-1-pyrrolidinecarboxylic acid tert-butyl ester (2S,4S)-4-[4-(3-Methyl-1-phenyl-1H-pyrazol-5-yl)-1-piperazinyl]-2-(3-thiazolidinylcarbonyl)-1-pyrrolidinecarboxylic acid tert-butyl ester 401566-80-1 C27H38N6O3S
trans-4,5-Dichloro-4,5-diMethyl-1,3-dioxolan-2-one trans-4,5-Dichloro-4,5-diMethyl-1,3-dioxolan-2-one 116857-05-7 C5H6Cl2O3
4-Methoxy-5-(3-Morpholinopropoxy)-2-nitrobenzaMide 4-Methoxy-5-(3-Morpholinopropoxy)-2-nitrobenzaMide 861453-16-9 C15H21N3O6
5-chloro-3-sulfo-2-Thiophenecarboxylic acid 5-chloro-3-sulfo-2-Thiophenecarboxylic acid 187746-94-7 C5H3ClO5S2
2,2'-(4,4'-(3,3'-(isopropylazanediyl)bis(2-hydroxypropane-3,1-diyl))bis(oxy)bis(4,1-phenylene))diacetaMide 2,2'-(4,4'-(3,3'-(isopropylazanediyl)bis(2-hydroxypropane-3,1-diyl))bis(oxy)bis(4,1-phenylene))diacetaMide 87619-83-8 C25H35N3O6
5-Methyl-4,5,6,7-tetrahydrothiazolo[5,4-c]pyridine-2-carboxylic acid hydrochloride 5-Methyl-4,5,6,7-tetrahydrothiazolo[5,4-c]pyridine-2-carboxylic acid hydrochloride 720720-96-7 C8H11ClN2O2S
3,3'-diMethyl-1,1'-diphenyl-1H,1'H-4,4'-bipyrazole-5,5'-diol 3,3'-diMethyl-1,1'-diphenyl-1H,1'H-4,4'-bipyrazole-5,5'-diol 177415-76-8 C20H18N4O2
5-(2-cyclopropyl-1-(3-fluorophenyl)-2-oxoethyl)-4,5,6,7-tetrahydrothieno[3,2-c]pyridin-2-yl acetate 5-(2-cyclopropyl-1-(3-fluorophenyl)-2-oxoethyl)-4,5,6,7-tetrahydrothieno[3,2-c]pyridin-2-yl acetate 1391194-39-0 C20H20FNO3S
Ceftriaxone IMpurit C Ceftriaxone IMpurit C
Flucloxacillin IMpurity G Flucloxacillin IMpurity G
Gefitinib N-Oxide Gefitinib N-Oxide 847949-51-3 C22H24ClFN4O4
Milrinone IMpurity 3 Milrinone IMpurity 3 98293-81-3 C12H7N3O3
Nicardipine Related CoMpound 4 Nicardipine Related CoMpound 4 123973-71-7 C25H27N3O6
PraMipexole IMp.BI-II786BS PraMipexole IMp.BI-II786BS
Propofol IMpurity E Propofol IMpurity E
Solifenacin Related CoMpound 5 Solifenacin Related CoMpound 5
TelMisartan BroMo Ethyl Ester TelMisartan BroMo Ethyl Ester 133085-87-7 C16H15BrO2
Tolterodine Lactol IMpurity Tolterodine Lactol IMpurity 209747-04-6 C16H16O2
Valsartan N1-Trityl IMpurity Valsartan N1-Trityl IMpurity
(3-Carbamoylallyl)trimethylammonium (3-Carbamoylallyl)trimethylammonium 857162-57-3 C7H15N2O+
3-CHLORO-4-HYDROXYACETANILIDE 3-CHLORO-4-HYDROXYACETANILIDE 3964-54-3 C8H8ClNO2
Apixaban IMpurity(BMS-591329-01) Apixaban IMpurity(BMS-591329-01)
ent-14S-3-Methoxy-17-MethylMorphinan ent-14S-3-Methoxy-17-MethylMorphinan 1453167-99-1 C18H25NO
PD 224378 PD 224378 501665-88-9 C20H35NO11
(rac,syn)-4-Deschloro-sertraline (rac,syn)-4-Deschloro-sertraline 871838-58-3 C17H18ClN
1-[2-(DiMethylaMino)-1-phenylethyl]cyclohexanol 1-[2-(DiMethylaMino)-1-phenylethyl]cyclohexanol 93413-86-6 C16H25NO
1-[4-(2-Methoxyethenyl)phenoxy]-3-[(1-Methylethyl)aMino]-2-propanol 1-[4-(2-Methoxyethenyl)phenoxy]-3-[(1-Methylethyl)aMino]-2-propanol 82961-02-2 C15H23NO3
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