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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
Ropivacaine-iPr Ropivacaine-iPr 175888-75-2 C17H26N2O
Demiditraz IMpurity Demiditraz IMpurity 944267-48-5 C19H18N2O
Apremilast impurity 18 Apremilast impurity 18 1407140-51-5 C20H32N2O6S
Betamethasone EP Impurity F Betamethasone EP Impurity F 330157-04-5 C22H28O4
Capecitabine Impurity 8 Capecitabine Impurity 8
Carfilzomib Impurity D Carfilzomib Impurity D
Cefodizime Impurity 4 Cefodizime Impurity 4
Cefradine impurity 5 Cefradine impurity 5 1379292-16-6 C10H17NO2
Clopidogrel Impurity 13 Clopidogrel Impurity 13 2173294-69-2 C16H16ClNO5S2
DecitaBine Impurity 12 DecitaBine Impurity 12
Erlotinib Impurity 28 Erlotinib Impurity 28
Fosaprepitant Impurity 12 Fosaprepitant Impurity 12 172673-19-7 C23H22F7N4O6P
Ibuprofen Impurity 2 Ibuprofen Impurity 2 C13H18O2
Imatinib Impurity 9 Imatinib Impurity 9
Isavuconazole Impurity 22 Isavuconazole Impurity 22
Isavuconazole Impurity 28 Isavuconazole Impurity 28
Levothyroxine Impurity 16 Levothyroxine Impurity 16 909279-46-5 C15H11ClI3NO4
Linagliptin Impurity 42 Linagliptin Impurity 42
8-Hydroxy Pitavastatin 8-Hydroxy Pitavastatin 224320-09-6 C25H24FNO5
α-Decitabine α-Decitabine 22432-95-7 C8H12N4O4
EMpagliflozin  iMpurity 10 EMpagliflozin iMpurity 10 2069942-68-1 C32H37ClO12
EMpagliflozin  iMpurity 15 EMpagliflozin iMpurity 15
(S)-8-(3-aMinopiperidin-1-yl)-7-(but-2-ynyl)-3-Methyl-1-((4-Methylquinazolin-2-yl)Methyl)-1H-purine-2,6(3H,7H)-dione (S)-8-(3-aMinopiperidin-1-yl)-7-(but-2-ynyl)-3-Methyl-1-((4-Methylquinazolin-2-yl)Methyl)-1H-purine-2,6(3H,7H)-dione 668269-51-0 C25H28N8O2
ibrutinib iMpurity B ibrutinib iMpurity B
Sunitinib iMpurity A Sunitinib iMpurity A
Sunitinib iMpurity F Sunitinib iMpurity F
(3R,4S)-1-(3-fluorophenyl)-3-((S)-3-(4-fluorophenyl)-3-hydroxypropyl)-4-(4-hydroxyphenyl)azetidin-2-one (3R,4S)-1-(3-fluorophenyl)-3-((S)-3-(4-fluorophenyl)-3-hydroxypropyl)-4-(4-hydroxyphenyl)azetidin-2-one 1700622-06-5 C24H21F2NO3
Betamethasone EP Impurity J Betamethasone EP Impurity J 18383-24-9 C22H30O4
Cefazedone Related Impurity 10 Cefazedone Related Impurity 10 18884-65-6 C10H12N2O5S
Etoricoxib Impurity 8 Etoricoxib Impurity 8 1421227-97-5 C22H20N2O4S
Mupirocin Impurity E Mupirocin Impurity E C26H44O9
Phenylephrine Impurity 1 Phenylephrine Impurity 1 C9H13NO2
Rupatadine Impurity B Rupatadine Impurity B 156523-04-5 C26H24ClN3O
Theophylline Impurity 1 Theophylline Impurity 1 5614-53-9 C9H10N4O3
Venlafaxine N-Dimer Venlafaxine N-Dimer 1187545-61-4 C32H48N2O4
Chrysin 6-C-glucoside 8-C-arabinoside Chrysin 6-C-glucoside 8-C-arabinoside 185145-34-0 C26H28O13
ent-Ivabradine Hydrochloride ent-Ivabradine Hydrochloride 148849-68-7 C27H37ClN2O5
Sofosbuvir metabolites GS566500 Sofosbuvir metabolites GS566500 1233335-78-8 C13H19FN3O9P
Ondansetron impurity G (PhEur) Ondansetron impurity G (PhEur) 99614-04-7 C17H18ClN3O
4-Hydroxy-1-methyl-7-phenoxy-3-isoquinolinecarboxylic acid methyl ester 4-Hydroxy-1-methyl-7-phenoxy-3-isoquinolinecarboxylic acid methyl ester 1421312-34-6 C18H15NO4
2-[(4-METHYLPHENOXY)METHYL]BENZOIC ACID 2-[(4-METHYLPHENOXY)METHYL]BENZOIC ACID 728-97-2 C15H14O3
Ethyl (1R,2R,3S,4R,5S)-4-acetamido-5-amino-2-azido-3- (1-ethylpropoxy)cyclohexanecarboxylate Ethyl (1R,2R,3S,4R,5S)-4-acetamido-5-amino-2-azido-3- (1-ethylpropoxy)cyclohexanecarboxylate 2124269-41-4 C16H29N5O4
PalBociclib Impurity 25 PalBociclib Impurity 25
Posaconazole Impurity 13 Posaconazole Impurity 13 357189-98-1 C37H40F2N8O6
Posaconazole Impurity 25 Posaconazole Impurity 25 1042398-26-4 C16H19F2IO3
Posaconazole Impurity 42 Posaconazole Impurity 42 357189-96-9 C36H40F2N8O5
Posaconazole Impurity 65 Posaconazole Impurity 65 2947625-11-6
Pramipexole Dimer Impurity (Mixture of Diastereomers) Pramipexole Dimer Impurity (Mixture of Diastereomers) 1147937-31-2 C13H23N3S
Sitafloxacin Impurity 1 Sitafloxacin Impurity 1
Sitagliptin Impurity 25 Sitagliptin Impurity 25
sofosBuvir impurity 47 sofosBuvir impurity 47
SofosBuvir Impurity 64 SofosBuvir Impurity 64
Tofacitinib Impurity W Tofacitinib Impurity W
Trelagliptin Impurity 21 Trelagliptin Impurity 21
Aloin Peracetate Aloin Peracetate 64951-96-8 C37H38O17
Tinnevellin glucoside Tinnevellin glucoside 80358-06-1 C20H24O9
L-Alanine, N-[(2,3,4,5,6-pentafluorophenoxy)phenoxyphosphinyl]-, 1-Methylethyl ester L-Alanine, N-[(2,3,4,5,6-pentafluorophenoxy)phenoxyphosphinyl]-, 1-Methylethyl ester 1256490-52-4 C18H17F5NO5P
Cefditoren iMpurity 2, Cefditoren open ring Cefditoren iMpurity 2, Cefditoren open ring
Ceftriaxone IMpurity C Ceftriaxone IMpurity C
Etoricoxib iMpurity 2 Etoricoxib iMpurity 2
Lorcaserin iMpurity D Lorcaserin iMpurity D 1030624-36-2 C11H14ClNO2
Ticagrelor IMpurity L (Mixture of DiastereoMers) Ticagrelor IMpurity L (Mixture of DiastereoMers)
α-Hydroxy-α-3-thienyl-2-thiopheneacetic Acid 9-Methyl-3-oxa-9-azatricyclo[3.3.1.02,4]non-7-yl Ester α-Hydroxy-α-3-thienyl-2-thiopheneacetic Acid 9-Methyl-3-oxa-9-azatricyclo[3.3.1.02,4]non-7-yl Ester 783273-13-2 C18H19NO4S2
3H-4,7a-Methanocyclohept[3,3a]indeno[5,4-b]oxete Benzenepropanoic Acid Derivative 3H-4,7a-Methanocyclohept[3,3a]indeno[5,4-b]oxete Benzenepropanoic Acid Derivative 146139-03-9 C47H51NO14
Fluvastatin 3-Hydroxy-4,6-diene Fluvastatin 3-Hydroxy-4,6-diene 1207963-21-0 C24H24FNO3
Cyclosporine iMpurity Cyclosporine iMpurity
ThiaMine IMpurity ThiaMine IMpurity C12H17ClN4OS
CitalopraM IMpurity CitalopraM IMpurity
3-(5-Methyl-3-phenylisoxazol-4-yl)benzenesulfonaMide 3-(5-Methyl-3-phenylisoxazol-4-yl)benzenesulfonaMide C16H14N2O3S
Tigecycline Tigecycline
1-((2R,3R,4R,5R)-3-chloro-4-hydroxy-5-(hydroxyMethyl)-3-Methyltetrahydrofuran-2-yl)pyriMidine-2,4(1H,3H)-dione 1-((2R,3R,4R,5R)-3-chloro-4-hydroxy-5-(hydroxyMethyl)-3-Methyltetrahydrofuran-2-yl)pyriMidine-2,4(1H,3H)-dione 1496551-72-4 C10H13ClN2O5
1-NaphthaleneMethanaMine, 7,8-dihydro-α-Methyl-N-[3-[3-(trifluoroMethyl)phenyl]propyl]-, hydrochloride (1:1), (αR)- 1-NaphthaleneMethanaMine, 7,8-dihydro-α-Methyl-N-[3-[3-(trifluoroMethyl)phenyl]propyl]-, hydrochloride (1:1), (αR)- 1020414-33-8 C22H25ClF3N
4,6-dichloro-2-(propylsulfinyl)pyriMidin-5-aMine 4,6-dichloro-2-(propylsulfinyl)pyriMidin-5-aMine 1823431-32-8 C7H9Cl2N3OS
Acetic acid, [[(3aR,4S,6R,6aS)-tetrahydro-2,2-diMethyl-6-[[(phenylMethoxy)carbonyl]aMino]-4H-cyclopenta-1,3-dioxol-4-yl]oxy]-, ethyl ester Acetic acid, [[(3aR,4S,6R,6aS)-tetrahydro-2,2-diMethyl-6-[[(phenylMethoxy)carbonyl]aMino]-4H-cyclopenta-1,3-dioxol-4-yl]oxy]-, ethyl ester 866551-95-3 C20H27NO7
4',6'-Dinitro-2'-phenoxymethanesulfonanilide 4',6'-Dinitro-2'-phenoxymethanesulfonanilide 51765-56-1 C13H11N3O7S
5-[1-Hydroxy-2-[(1-methyl-3-phenylpropyl)amino]ethyl]salicylic acid methyl ester hydrochloride 5-[1-Hydroxy-2-[(1-methyl-3-phenylpropyl)amino]ethyl]salicylic acid methyl ester hydrochloride 33778-93-7 C20H26ClNO4
Blonanserin Impurity I Blonanserin Impurity I
25,26,26,26,27,27-hexadeuterocholest-5-ene-3,27-diol 25,26,26,26,27,27-hexadeuterocholest-5-ene-3,27-diol 1246302-95-3 C27H40D6O2
2-Azabicyclo[3.1.0]hexane-3-carbonitrile, 2-[(2R)-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-[(2R)-2-aMino-2-(3-hydroxytricyclo[3.3.1.13,7]dec-1-yl)acetyl]-, (1R,3R,5R)- 1564265-95-7 C18H25N3O2
(1S,5R,6R)-5-Hydroxy-7-oxabicyclo[4.1.0]hept-3-ene-3-carboxylic Acid Ethyl Ester (1S,5R,6R)-5-Hydroxy-7-oxabicyclo[4.1.0]hept-3-ene-3-carboxylic Acid Ethyl Ester 876014-27-6 C9H12O4
(3R,5R)-Rosuvastatin Lactone (3R,5R)-Rosuvastatin Lactone 1422954-11-7 C22H26FN3O5S
(S)-4,5,6,7-Tetrahydro-2,6-benzothiazolediamine (S)-4,5,6,7-Tetrahydro-2,6-benzothiazolediamine 1867177-06-7 C9H13N3OS
Letrozole Impurity Letrozole Impurity
Alogliptin Impurity C Alogliptin Impurity C 1108731-49-2 C20H23N5O3
Alogliptin Impurity C Alogliptin Impurity C 1108731-49-2 C20H23N5O3
Parecoxib Impurity J Parecoxib Impurity J
6-(4-(4-(benzo[b]thiophen-4-yl)piperazin-1-yl)butoxy)-1-(4-(2-oxo-1,2-dihydroquinolin-7-yloxy)butyl)quinolin-2(1H)-one 6-(4-(4-(benzo[b]thiophen-4-yl)piperazin-1-yl)butoxy)-1-(4-(2-oxo-1,2-dihydroquinolin-7-yloxy)butyl)quinolin-2(1H)-one C38H40N4O4S
Atracurium Impurity F Atracurium Impurity F
Linagliptin Impurity J Linagliptin Impurity J
Linagliptin Impurity Q Linagliptin Impurity Q
(R)-2-(((1-(3-(2-cyano-5-fluorobenzyl)-1-methyl-2,6-dioxo-1,2,3,6-tetrahydropyrimidin-4-yl)piperidin-3-yl)amino)methyl)-4-fluorobenzonitrile (R)-2-(((1-(3-(2-cyano-5-fluorobenzyl)-1-methyl-2,6-dioxo-1,2,3,6-tetrahydropyrimidin-4-yl)piperidin-3-yl)amino)methyl)-4-fluorobenzonitrile C26H24F2N6O2
Rosuvastatin Calcium Impurity Rosuvastatin Calcium Impurity
Canagliflozin Monoacetyl Impurity Canagliflozin Monoacetyl Impurity
Etoricoxib Impurity 13 Etoricoxib Impurity 13 1817735-82-2 C25H20ClN3O3S
Mirabegron Impurity 11 Mirabegron Impurity 11 1684452-85-4 C21H24N4O2S
Riociguat Impurtiy 2 Riociguat Impurtiy 2
Topiroxostat Impurity 9 Topiroxostat Impurity 9 577778-82-6 C13H8N6O
Vonoprazan Impurity F Vonoprazan Impurity F
Vortioxetine Impurity 15 Vortioxetine Impurity 15 2099147-02-9 C28H34N4S2
Dapagliflozin Impurity H Dapagliflozin Impurity H
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