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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
Fondaparinux sodium impurity 12 Fondaparinux sodium impurity 12
Piperacillin impurity L Piperacillin impurity L
Piperacillin  Impurity X Piperacillin Impurity X
ETHYLTRITYLETHER ETHYLTRITYLETHER 968-39-8 C21H20O
Bosutinib Impurity 41 Bosutinib Impurity 41
(S)-3-Dimethylamino-3-phenylpropanol (S)-3-Dimethylamino-3-phenylpropanol 82769-75-3 C11H17NO
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
Carbonic acid, dichloromethyl methyl ester Carbonic acid, dichloromethyl methyl ester 207804-63-5 C3H4Cl2O3
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
3-[(Dimethylamino)methyl]-9-methyl-1,2,3,9-tetrahydro-4H-carbazol-4-one 3-[(Dimethylamino)methyl]-9-methyl-1,2,3,9-tetrahydro-4H-carbazol-4-one 153139-56-1 C16H20N2O
Roxithromycin Impurity K Roxithromycin Impurity K
N-(2-HYDROXYETHYL)ISONICOTINAMIDE, 99 N-(2-HYDROXYETHYL)ISONICOTINAMIDE, 99 6265-74-3 C8H10N2O2
BENAZEPRIL RELATED COMPOUND G (15 MG) ((3-(1 -ETHOXYCARBONYL-3-PHENYL-(1 S)-PROPYL)AMINO-2,3,4,5-TETRAHYDRO-2-OXO-1H-1-(3S)-BENZAZE-PINE)-1-ACETIC ACID, ETHYL ESTER) BENAZEPRIL RELATED COMPOUND G (15 MG) ((3-(1 -ETHOXYCARBONYL-3-PHENYL-(1 S)-PROPYL)AMINO-2,3,4,5-TETRAHYDRO-2-OXO-1H-1-(3S)-BENZAZE-PINE)-1-ACETIC ACID, ETHYL ESTER) 103129-58-4 C26H32N2O5
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
Tofacitinib Related Compound 16 Tofacitinib Related Compound 16 2183519-70-0 C15H23N5
Vortioxetine Impurity 8 Vortioxetine Impurity 8
Erlotinib Impurity 21 Erlotinib Impurity 21
Fluvastatin EP Impurity C Fluvastatin EP Impurity C 779995-42-5 C24H26FNO4
Oseltamivir Impurity 17 Oseltamivir Impurity 17 2413185-88-1 C14H22O4
Topiroxostat Impurity 15 Topiroxostat Impurity 15
Teneligliptin Impurity 10 Di-Trifluoroacetate Teneligliptin Impurity 10 Di-Trifluoroacetate
Posaconazole iMpurity 68 Posaconazole iMpurity 68
Erlotinib Hydrochloride iMpurity 50 Erlotinib Hydrochloride iMpurity 50
(S)-methyl 9,10-difluoro-3-methyl-7-oxo-3,7-dihydro-2H-[1,4]oxazino [2,3,4-ij]quinoline-6-carboxylate (S)-methyl 9,10-difluoro-3-methyl-7-oxo-3,7-dihydro-2H-[1,4]oxazino [2,3,4-ij]quinoline-6-carboxylate 1213269-49-8 C14H11F2NO4
Vonoprazan Impurity U3 Vonoprazan Impurity U3
Prucalopride Impurity 10/ethyl 4-(4-amino-5-chloro-2,3-dihydrobenzofuran-7-carboxamido)piperidine-1-carboxylate Prucalopride Impurity 10/ethyl 4-(4-amino-5-chloro-2,3-dihydrobenzofuran-7-carboxamido)piperidine-1-carboxylate 137211-63-3 C17H22ClN3O4
Cefonicid Impurity 1 Cefonicid Impurity 1
1589503-93-4 1589503-93-4 1589503-93-4 C27H24F2N6O3S
(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
5-(hydroxymethyl)-3-[(5-nitro-2-furyl)methylideneamino]oxazolidin-2-one 5-(hydroxymethyl)-3-[(5-nitro-2-furyl)methylideneamino]oxazolidin-2-one 41359-15-3 C9H9N3O6
Ambrisentan Impurity E Ambrisentan Impurity E 1312092-82-2 C21H18N2O3
ethyl 2-(4-butoxy-3-cyanophenyl)-4-methylthiazole-5-
carboxylate ethyl 2-(4-butoxy-3-cyanophenyl)-4-methylthiazole-5- carboxylate 2230270-05-8 C18H20N2O3S
Cefminox Sodium Impurity 6 Cefminox Sodium Impurity 6
Flurbiprofen Impurity 7 Flurbiprofen Impurity 7
Imidafenacin Impurity 8 Imidafenacin Impurity 8 503598-05-8 C20H21N3O3
Pregabalin Impurity E Pregabalin Impurity E 1239692-16-0 C11H24ClNO2
Rosuvastatin Impurity 86 Rosuvastatin Impurity 86
Cefathiamidine Impurity 8 Cefathiamidine Impurity 8
Urapidil impurity 7 Urapidil impurity 7 108997-11-1 C24H34N4O2
methyl 3-[[4-chloro-2-(phenylamino)phenyl]methylamino]-3-oxopropanoate. methyl 3-[[4-chloro-2-(phenylamino)phenyl]methylamino]-3-oxopropanoate. 2089061-92-5 C17H17ClN2O3
Pregabalin Impurity 15 Pregabalin Impurity 15
Pregabalin Impurity 32 Pregabalin Impurity 32
4-Hydroxyphthalic Acid 4-Hydroxyphthalic Acid 501666-22-4 C14H25NO6
Bepotastine N-Oxide Impurity Bepotastine N-Oxide Impurity
Nintedanib Impurity 25 Nintedanib Impurity 25
Tripterygium glycosides Tripterygium glycosides
(RS)-3-tert-butyl 4-ethyl thiazolidine-3,4-dicarboxylate (RS)-3-tert-butyl 4-ethyl thiazolidine-3,4-dicarboxylate C11H19NO4S
(1s,4s)-4-((2-amino-3-bromobenzyl)amino)cyclohexan-1-ol hydrochloride (1s,4s)-4-((2-amino-3-bromobenzyl)amino)cyclohexan-1-ol hydrochloride C13H20BrClN2O
Edaravone Impurity 19 Edaravone Impurity 19
Linagliptin Impurity 48 Linagliptin Impurity 48
(3R,5S,E)-methyl 3,5-dihydroxy-7-(4-isopropyl-2-(N-methylmethyl sulfonamido)-6-phenylpyrimidin-5-yl)hept-6-enoate (3R,5S,E)-methyl 3,5-dihydroxy-7-(4-isopropyl-2-(N-methylmethyl sulfonamido)-6-phenylpyrimidin-5-yl)hept-6-enoate C23H31N3O6S
(R)-3,5-dibromo-N-((1-ethylpyrrolidin-2-yl)methyl)-2,6-dimethoxybenzamide (R)-3,5-dibromo-N-((1-ethylpyrrolidin-2-yl)methyl)-2,6-dimethoxybenzamide C16H22Br2N2O3
Mesna Impurity 1 (2-Ethoxy-Ethanesulfonic Acid) Mesna Impurity 1 (2-Ethoxy-Ethanesulfonic Acid) 90663-51-7 C4H10O4S
Vonoprazan Impurity Z-7 Vonoprazan Impurity Z-7
Caspofungin Impurity QA Caspofungin Impurity QA
Cabozantinib impurity 27 Cabozantinib impurity 27
Cabozantinib impurity 32 Cabozantinib impurity 32
Rivaroxaban Degradation Impurity B Rivaroxaban Degradation Impurity B
Dapoxetine impurity 26 Dapoxetine impurity 26
Pregabalin Impurity 12 Pregabalin Impurity 12 1013624-61-7 C7H11NO3
Pralatrexate Impurity 6 Pralatrexate Impurity 6
Pitavastatin Impurity 37 Pitavastatin Impurity 37
Dapoxetine impurity 30 Dapoxetine impurity 30
Lenvatinib Impurity 34 Lenvatinib Impurity 34
Sitafloxacin Impurity 18 Sitafloxacin Impurity 18
Canagliflozin Impurity 47 Canagliflozin Impurity 47
Olprinone Impurity C Olprinone Impurity C
Atracurium Impurity 29 Atracurium Impurity 29
Posaconazole Impurity 71 Posaconazole Impurity 71
Canagliflozin Impurity 53 Canagliflozin Impurity 53
Atracurium Impurity 32 Atracurium Impurity 32
Tofacitinib Impurity 104 Tofacitinib Impurity 104
Rotigotine Impurity 1 Rotigotine Impurity 1
Afatinib impurity 49 Afatinib impurity 49
Afatinib impurity 49 Afatinib impurity 49
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