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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
11-Desethyl Irinotecan 11-Desethyl Irinotecan 103816-16-6 C31H34N4O6
5-Methoxy-2-[[(4-Methoxy-3,5-diMethyl-2-pyridinyl)Methyl]thio]-1H-benziMidazole N-Oxide 5-Methoxy-2-[[(4-Methoxy-3,5-diMethyl-2-pyridinyl)Methyl]thio]-1H-benziMidazole N-Oxide 142885-92-5 C17H19N3O3S
7-[[[(CyanoMethyl)thio]acetyl]aMino]-7-Methoxy Cephalosporanic Acid 7-[[[(CyanoMethyl)thio]acetyl]aMino]-7-Methoxy Cephalosporanic Acid 56796-16-8 C15H17N3O7S2
7S-Cefdinir 7S-Cefdinir 178601-89-3 C14H13N5O5S2
Dehydroxy BroMocelecoxib Dehydroxy BroMocelecoxib 170570-75-9 C17H13BrF3N3O2S
Desethylene Norfloxacin Hydrochloride Desethylene Norfloxacin Hydrochloride 75001-77-3 C14H16FN3O3
p-(2,3-Epoxypropoxy)benzyl Alcohol p-(2,3-Epoxypropoxy)benzyl Alcohol 4204-78-8 C10H12O3
α-Etoposide α-Etoposide 100007-53-2 C29H32O13
N-Desmethyl-N-benzyl Sildenafil N-Desmethyl-N-benzyl Sildenafil 1446089-82-2 C28H34N6O4S
4-Hydroxy AtoMoxetine Oxalate 4-Hydroxy AtoMoxetine Oxalate 457634-21-8 C19H23NO6
6-Chloro-1-Ethyl-4-Oxo-7-(Piperazin-1-yl)-1,4-Dihydroquinoline-3-Carboxylic acid 6-Chloro-1-Ethyl-4-Oxo-7-(Piperazin-1-yl)-1,4-Dihydroquinoline-3-Carboxylic acid 67681-84-9 C16H18ClN3O3
Afatinib IMpurity J Afatinib IMpurity J 1456696-14-2 C18H22N4O4
Aprepitant iMpurity A Aprepitant iMpurity A
Atorvastatin LactaM Phenanthrene CalciuM Salt Atorvastatin LactaM Phenanthrene CalciuM Salt 1046378-58-8 C33H35CaFN2O6
Avanafil IMpurity 7 Avanafil IMpurity 7
Desfluoro flurbiprofen axetil Desfluoro flurbiprofen axetil 1685278-08-3 C19H20O4
Desloratadine IMpurity 6 Desloratadine IMpurity 6 38092-90-9 C20H21ClN2
ErtapeneM Ring Open IMpurity ErtapeneM Ring Open IMpurity
2-Thiopheneacetic acid, α-hydroxy-α-2-thienyl-, (3R)-1-azabicyclo[2.2.2]oct-3-yl ester 2-Thiopheneacetic acid, α-hydroxy-α-2-thienyl-, (3R)-1-azabicyclo[2.2.2]oct-3-yl ester 320347-97-5 C17H19NO3S2
benzbroMarone iMpurity benzbroMarone iMpurity
Dasatinib iMpurity Dasatinib iMpurity 1184919-23-0 C22H27N7O2S
eszopiclone iMpurity eszopiclone iMpurity
IMidafenacin iMpurity IMidafenacin iMpurity 503599-41-5 C18H20N2O2
latanoprost iMpurity latanoprost iMpurity 733036-95-8 C25H35FO5
Irbesartan IMpurity D Irbesartan IMpurity D C25H28N6O
LincoMycin iMpurity C LincoMycin iMpurity C
Norfloxacin iMpurity E Norfloxacin iMpurity E
Posaconazole iMpurity 2 Posaconazole iMpurity 2
Quetiapine IMpurity [2-(2-Piperazin-1-yl)ethoxy)ethanol] Quetiapine IMpurity [2-(2-Piperazin-1-yl)ethoxy)ethanol] 2206135-50-2 C25H18N2S2
Rabeprazole iMpurity (Chloro interMediate) Rabeprazole iMpurity (Chloro interMediate)
TaMsulosin IMpurity F TaMsulosin IMpurity F C20H28N2O5S
TiaMulin IMpurity E (TiaMulone,11-Oxo TiaMulin) TiaMulin IMpurity E (TiaMulone,11-Oxo TiaMulin) 113323-39-0 C28H45NO4S
2-(2-(4-(Dibenzo[b,f][1,4]thiazepin-11-yl)piperazin-1-yl)ethoxy)ethanol 2-(2-(4-(Dibenzo[b,f][1,4]thiazepin-11-yl)piperazin-1-yl)ethoxy)ethanol 848814-27-7 C21H27N3O3S
(3aR,7R,7aR)-2,2-Diethyl-3a,6,7,7a-tetrahydro-7-[(Methylsulfonyl)oxy]-1,3-benzodioxole-5-carboxylic Acid Ethyl Ester (3aR,7R,7aR)-2,2-Diethyl-3a,6,7,7a-tetrahydro-7-[(Methylsulfonyl)oxy]-1,3-benzodioxole-5-carboxylic Acid Ethyl Ester 204254-90-0 C15H24O7S
TorseMide Carboxylic Acid TorseMide Carboxylic Acid 113844-99-8 C16H18N4O5S
(3S,5R)-Fluvastatin SodiuM Salt (3S,5R)-Fluvastatin SodiuM Salt 94061-81-1 C24H25FNNaO4
(6-BroMo-2-ethyl-3-benzofuranyl)(3,5-dibroMo-4-hydroxyphenyl)Methanone (6-BroMo-2-ethyl-3-benzofuranyl)(3,5-dibroMo-4-hydroxyphenyl)Methanone 1402819-05-9 C17H11Br3O3
ApreMilast IMpurity ApreMilast IMpurity 2438558-63-3 C21H22N2O7S
5'-broMo-[2,3'-bipyridin]-6'(1'H)-one 5'-broMo-[2,3'-bipyridin]-6'(1'H)-one 381233-79-0 C10H7BrN2O
EMpagliflozin  iMpurity 8 EMpagliflozin iMpurity 8
EMpagliflozin  iMpurity 13 EMpagliflozin iMpurity 13 2125472-55-9 C23H25ClO8
6-Methyldi(ondansetron-3-de(1,2-diMethyl-1H-iMidazole)) 6-Methyldi(ondansetron-3-de(1,2-diMethyl-1H-iMidazole)) 1365727-07-6 C27H26N2O2
(-)-Syringaresinol-4-O-beta-D-glucopyranoside (-)-Syringaresinol-4-O-beta-D-glucopyranoside 137038-13-2 C28H36O13
Budesonide Impurity (1, 4-Androstadien-11-beta-16-alfa-diol-3, 17-dione) Budesonide Impurity (1, 4-Androstadien-11-beta-16-alfa-diol-3, 17-dione) 910299-74-0 C19H24O4
Etoricoxib Impurity 12 Etoricoxib Impurity 12 646459-41-8 C21H16ClN3O2S
Levofloxacin Tetrafluoro Impurity 2 Levofloxacin Tetrafluoro Impurity 2 103995-33-1 C14H12F4O4
Mupirocin Impurity C Mupirocin Impurity C C26H44O9
Verapamil Impurity H Verapamil Impurity H 67018-83-1 C26H36N2O4
Warfarin Impurity 1 Warfarin Impurity 1 55901-61-6 C13H14O
Vitexin -4''-O-glucoside Vitexin -4''-O-glucoside 178468-00-3 C27H30O15
Aripiprazole EP impurity D Aripiprazole EP impurity D
Macitentan impurity B Macitentan impurity B 441796-13-0 C18H18Br2N6O4S
Meropenem IMP B Meropenem IMP B
tert-butyl 4-(6-bromopyridin-3-yl)piperazine-1-carboxylate tert-butyl 4-(6-bromopyridin-3-yl)piperazine-1-carboxylate 412348-27-7 C14H20BrN3O2
4-(2,3-DIMETHYL-BENZYL)-1H-IMIDAZOLE HCL H2O 4-(2,3-DIMETHYL-BENZYL)-1H-IMIDAZOLE HCL H2O 90038-00-9 C12H17ClN2O
Metoprolol Acid Ethyl Ester Metoprolol Acid Ethyl Ester 29112-40-1 C16H25NO4
6-Hydroxy Desloratadine 6-Hydroxy Desloratadine 119410-05-8 C19H19ClN2O
10-Acetyloxy Oxcarbazepine 10-Acetyloxy Oxcarbazepine 113952-21-9 C17H14N2O4
(S)-N-Demethyl Dapoxetine (S)-N-Demethyl Dapoxetine 147199-39-1 C20H21NO
Famotidine Related Compound A Hydrochloride Famotidine Related Compound A Hydrochloride 76833-47-1 C8H15ClN6S2
Des(trifluoroethyl) Lansoprazole Sulfide Des(trifluoroethyl) Lansoprazole Sulfide 131926-97-1 C14H13N3OS
Desulfo Aztreonam Desulfo Aztreonam 102579-59-9 C13H17N5O5S
(2S,3S,5S)-2-Hexyl-3,5-dihydroxyhexadecanoic Acid 
(2S,3S,5S)-2-Hexyl-3,5-dihydroxyhexadecanoic Acid 130793-30-5 C22H44O4
Ondansetron HCl IMpurity-G Ondansetron HCl IMpurity-G 99614-03-6 C17H17N3O
lithiuM 2-(4-(Methylsulfonyl)phenyl)acetate lithiuM 2-(4-(Methylsulfonyl)phenyl)acetate 1421227-96-4 C9H11LiO4S
Anastrozole IMpurity (3-(1-Cyano-1-Methylethyl)-alfa,alfa-diMethyl-5-(1H-,1,2,4-triazole-1-ylMethyl)-benzeneacetaMide) Anastrozole IMpurity (3-(1-Cyano-1-Methylethyl)-alfa,alfa-diMethyl-5-(1H-,1,2,4-triazole-1-ylMethyl)-benzeneacetaMide) 120512-03-0 C17H21N5O
AtracuriuM IMpurity I (Mixture of cis, trans(I1), cis, cis(I2), tans, trans IsoMer) AtracuriuM IMpurity I (Mixture of cis, trans(I1), cis, cis(I2), tans, trans IsoMer)
1-((2R,3R)-2-(benzyloxy)pentan-3-yl)-4-(4-(4-(4-hydroxyphenyl)piperazin-1-yl)phenyl)-1H-1,2,4-triazol-5(4H)-one 1-((2R,3R)-2-(benzyloxy)pentan-3-yl)-4-(4-(4-(4-hydroxyphenyl)piperazin-1-yl)phenyl)-1H-1,2,4-triazol-5(4H)-one 2243786-01-6 C30H35N5O3
5-(3-fluorophenyl)-1H-pyrrole-3-carbaldehyde 5-(3-fluorophenyl)-1H-pyrrole-3-carbaldehyde C11H8FNO
1,4-Dihydro-2,6-dimethyl-4-(3-nitrophenyl)-3,5-pyridinedicarboxylic acid bis(1-methylethyl) ester 1,4-Dihydro-2,6-dimethyl-4-(3-nitrophenyl)-3,5-pyridinedicarboxylic acid bis(1-methylethyl) ester 21881-78-7 C21H26N2O6
2-(4-Methylphenyl)sulfonyloxyethanol 2-(4-Methylphenyl)sulfonyloxyethanol 42772-85-0 C9H12O4S
2-Azabicyclo[3.1.0]hexane-3-carbonitrile, 2-[(2S)-2-aMino-2-(3-hydroxytricyclo[3.3.1.13,7]dec-1-yl)acetyl]-, (1R,3R,5R)- 2-Azabicyclo[3.1.0]hexane-3-carbonitrile, 2-[(2S)-2-aMino-2-(3-hydroxytricyclo[3.3.1.13,7]dec-1-yl)acetyl]-, (1R,3R,5R)- 1564265-94-6 C18H25N3O2
(2R,4R)-5-(Biphenyl-4-yl)-4-[(tert-butoxycarbonyl)amino]-2-methylpentanoic acid (2R,4R)-5-(Biphenyl-4-yl)-4-[(tert-butoxycarbonyl)amino]-2-methylpentanoic acid 1012341-56-8 C23H29NO4
Alogliptin Impurity A Alogliptin Impurity A
Linagliptin Impurity D Linagliptin Impurity D 666816-91-7 C20H28N6O4
Parecoxib Impurity C Parecoxib Impurity C 3026677-40-4
Rac Atomoxetine Hydrochloride Rac Atomoxetine Hydrochloride 82857-40-7 C17H22ClNO
3-(1H-imidazol-1-yl)-5-(trifluoromethyl)aniline 3-(1H-imidazol-1-yl)-5-(trifluoromethyl)aniline 943320-48-7 C10H8F3N3
Linagliptin Impurity H Linagliptin Impurity H 1646355-34-1 C22H23N7O2
Ezetimibe Impurity 54 Ezetimibe Impurity 54 1185883-39-9 C40H36F2N2O5
2-(2-fluorophenyl)-1,3-di(1H-1,2,4-triazol-1-yl)propan-2-ol 2-(2-fluorophenyl)-1,3-di(1H-1,2,4-triazol-1-yl)propan-2-ol 1348664-75-4 C13H13FN6O
Dapagliflozin Impurity 2 Dapagliflozin Impurity 2
Imatinib Impurity 1 Imatinib Impurity 1
Imatinib Impurity 6 Imatinib Impurity 6
Nifedipine Impurity 3 Nifedipine Impurity 3 C19H22N2O6
Riociguat Impurtiy 5 Riociguat Impurtiy 5
Vonoprazan Impurity 6 Vonoprazan Impurity 6
Avibactam Impurity Avibactam Impurity 1797133-98-2 C7H12N3NaO6S
Citalopram EP Impurity E Citalopram EP Impurity E 64169-47-7 C19H22Cl2FNO
Dapagliflozin Impurity F Dapagliflozin Impurity F
Dapoxetine Impurity A Dapoxetine Impurity A
Entecavir  Impurity Entecavir Impurity 1333204-94-6 C12H15N5O3
Gadobutrol Impurity Gadobutrol Impurity
Lesinurad Impurity Lesinurad Impurity
Pramipexole Impurity G Pramipexole Impurity G
Salmeterol EP Impurity A Salmeterol EP Impurity A 1798014-51-3 C19H25NO3
Tacrolimus impurity D Tacrolimus impurity D
2-(2-(4-(2-(4-(1-(2-ethoxyethyl)-1H-benzo[d]imidazol-2-yl)piperidin-1-yl)ethyl)phenyl)propan-2-yl)-4,4-dimethyl-4,5-dihydrooxazole 2-(2-(4-(2-(4-(1-(2-ethoxyethyl)-1H-benzo[d]imidazol-2-yl)piperidin-1-yl)ethyl)phenyl)propan-2-yl)-4,4-dimethyl-4,5-dihydrooxazole 202189-77-3 C32H44N4O2
Saxagliptin Impurity 6 Saxagliptin Impurity 6
Alcaftadine N-Oxide Alcaftadine N-Oxide 952649-75-1 C19H21N3O2
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