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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
Moxifloxacin Impurity Moxifloxacin Impurity 1797982-51-4 C16H16FNO5
sofosBuvir impurity 1 sofosBuvir impurity 1
2-(3-cyano-4-isopropoxyphenyl)-4-methylthiazole-5-carboxylic acid 2-(3-cyano-4-isopropoxyphenyl)-4-methylthiazole-5-carboxylic acid 144060-52-6 C15H14N2O3S
Alogliptin Related Compound 26 Alogliptin Related Compound 26 865759-10-0 C25H24N6O2
R-Tirofiban R-Tirofiban 158808-86-7 C22H36N2O5S
Canagliflozin Impurity 20 Canagliflozin Impurity 20
Canagliflozin Impurity 6 Canagliflozin Impurity 6
Carfilzomib Impurity 6 Carfilzomib Impurity 6
Daclatasvir Impurity 5 (SRSS-Isomer) Daclatasvir Impurity 5 (SRSS-Isomer) 1009117-28-5 C40H50N8O6
Dolutegravir Impurity 7 Dolutegravir Impurity 7 2244161-71-3 C20H21N3O5
Istradefylline Impurity F Istradefylline Impurity F
Linagliptin Impurity 22 Linagliptin Impurity 22
Nintedanib impurity G Nintedanib impurity G 894783-61-0 C30H31N5O4
3,3′-[(2-methylbenzene-1,3-diyl)bis(oxy)]bis(N-methyl- 3-phenylpropan-1-amine) 3,3′-[(2-methylbenzene-1,3-diyl)bis(oxy)]bis(N-methyl- 3-phenylpropan-1-amine) 1010818-93-5 C27H34N2O2
Febuxostat impurity 36 Febuxostat impurity 36 1805770-40-4 C12H12N2O
N-[1-[(3R)-1-(1-oxo-2-propen-1-yl)-3-piperidinyl]-3-(4-phenoxyphenyl)-1H-pyrazolo[3,4-d]pyrimidin-4-yl]- 2-Propenamide N-[1-[(3R)-1-(1-oxo-2-propen-1-yl)-3-piperidinyl]-3-(4-phenoxyphenyl)-1H-pyrazolo[3,4-d]pyrimidin-4-yl]- 2-Propenamide 2031255-27-1 C28H26N6O3
4-amino-5-fluoro-1-((2R,5S)-2-(hydroxymethyl)-3-oxido-1,3-oxathiolan-5-yl)pyrimidin-2(1H)-one 4-amino-5-fluoro-1-((2R,5S)-2-(hydroxymethyl)-3-oxido-1,3-oxathiolan-5-yl)pyrimidin-2(1H)-one C8H11FN3O4S-
Anastrozole Impurity 3 Anastrozole Impurity 3
Cephalexin Impurity 4 Cephalexin Impurity 4 C16H17N3O4S
Rivaroxaban Impurity 42 Rivaroxaban Impurity 42
(R,E)-7-(4-(4-fluorophenyl)-6-isopropyl-2-(N-methylmethylsulfonamido)pyrimidin-5-yl)-3-hydroxy-5-oxohept-6-enoic acid (R,E)-7-(4-(4-fluorophenyl)-6-isopropyl-2-(N-methylmethylsulfonamido)pyrimidin-5-yl)-3-hydroxy-5-oxohept-6-enoic acid 1422514-05-3 C22H26FN3O6S
Atorvastatin 2-Fluoro t-Butyl Ester Atorvastatin 2-Fluoro t-Butyl Ester 1099474-28-8 C40H47FN2O5
Cabozantinib Impurity C Cabozantinib Impurity C
(3R,4R)-N,4-dimethyl-piperidin-3-amine (3R,4R)-N,4-dimethyl-piperidin-3-amine 1354469-76-3 C7H16N2
4-(1H-Pyrazol-4-yl)-7H-pyrrolo[2,3-d]pyrimidine 4-(1H-Pyrazol-4-yl)-7H-pyrrolo[2,3-d]pyrimidine 952518-97-7 C9H7N5
5-phenyl-1-(pyridin-3-ylsulfonyl)-1H-pyrrole-3-carbaldehyde 5-phenyl-1-(pyridin-3-ylsulfonyl)-1H-pyrrole-3-carbaldehyde 881676-90-0 C16H12N2O3S
3-Piperidinemethanol, 4-(4-fluorophenyl)-1-methyl-, (3R,4R)- 3-Piperidinemethanol, 4-(4-fluorophenyl)-1-methyl-, (3R,4R)- 100332-12-5 C13H18FNO
r-Cytidine r-Cytidine 13913-16-1 C9H13N3O5
Pyridine, 4-chloro-2-(chloromethyl)-3-methyl- Pyridine, 4-chloro-2-(chloromethyl)-3-methyl- 168167-48-4 C7H7Cl2N
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
Betamethasone EP Impurity H Betamethasone EP Impurity H 185613-71-2 C22H29FO5
Blonanserin Impurity 10 Blonanserin Impurity 10 132810-87-8 C23H30ClN3
Blonanserin impurity G Blonanserin impurity G
Cefodizime Impurity 5 Cefodizime Impurity 5
Clindamycin Impurity 4 Clindamycin Impurity 4
Doxofylline Impurity 4 Doxofylline Impurity 4 2095554-12-2 C11H16N4O5
Eltrombopag Impurity 1 Eltrombopag Impurity 1 1246929-02-1 C25H23N5O3
Everolimus impurity A Everolimus impurity A
Fosaprepitant Impurity 13 Fosaprepitant Impurity 13
Gefitinib Impurity J Gefitinib Impurity J
Isavuconazole Impurity 23 Isavuconazole Impurity 23
Isavuconazole Impurity 29 Isavuconazole Impurity 29
Isavuconazole Impurity 7 Isavuconazole Impurity 7
Lercanidipine Impurity 6 Lercanidipine Impurity 6 786625-22-7 C37H43N3O6
Linagliptin Impurity 43 Linagliptin Impurity 43
MiraBegron Impurity A MiraBegron Impurity A
Moxifloxacin Impurity 15 Moxifloxacin Impurity 15
Moxifloxacin Impurity 32 Moxifloxacin Impurity 32
Nifedipine Impurity F Nifedipine Impurity F 53055-15-5 C18H20N2O6
Olaparib Impurity 15 Olaparib Impurity 15 2250243-17-3 C24H25FN4O3
HERBACETIN-3,8-DIGLUCOPYRANOSIDE HERBACETIN-3,8-DIGLUCOPYRANOSIDE 99224-12-1 C27H30O17
2-(4-HYDROXY-PHENYL)-4-METHYL-THIAZOLE-5-CARBOXYLIC ACID 2-(4-HYDROXY-PHENYL)-4-METHYL-THIAZOLE-5-CARBOXYLIC ACID 886501-78-6 C11H9NO3S
(3R,5R)-Fluvastatin Sodium Salt (3R,5R)-Fluvastatin Sodium Salt 194934-99-1 C24H27FNNaO4
Orlistat Dihydropyranone Impurity Orlistat Dihydropyranone Impurity 130676-64-1 C22H40O2
(S)-PYRROLIDINE-2-CARBONITRILE (S)-PYRROLIDINE-2-CARBONITRILE 204387-53-1 C5H8N2
1-(CHLOROACETYL)-L-PROLINE METHYL ESTER 1-(CHLOROACETYL)-L-PROLINE METHYL ESTER 38074-72-5 C8H12ClNO3
1-(4-PIPERIDINYLCARBONYL)-4-PIPERIDINECARBOXYLIC ACID 1-(4-PIPERIDINYLCARBONYL)-4-PIPERIDINECARBOXYLIC ACID 96053-48-4 C12H20N2O3
1-(3-PYRIDYL)ETHAN-1-ONE OXIME 1-(3-PYRIDYL)ETHAN-1-ONE OXIME 5973-83-1 C7H8N2O
1-(3,4,5-Trimethoxy-benzyl)-piperazinedihydrochloride 1-(3,4,5-Trimethoxy-benzyl)-piperazinedihydrochloride 107049-57-0 C14H24Cl2N2O3
Sitagliptin N-Sulfate Sitagliptin N-Sulfate 940002-57-3 C16H15F6N5O4S
1-Oxo Mirtazapine (Mirtazapine Impurity C) 1-Oxo Mirtazapine (Mirtazapine Impurity C) 191546-96-0 C17H17N3O
(3S,4S)-3-Hexyl-4-[(S)-2-hydroxytridecyl]-2-oxetanone (3S,4S)-3-Hexyl-4-[(S)-2-hydroxytridecyl]-2-oxetanone 68711-40-0 C22H42O3
N-(2,6-Dimethylphenyl)-2-(ethylmethylamino)acetamide Hydrochloride_x000b_(Lidocaine Impurity E) N-(2,6-Dimethylphenyl)-2-(ethylmethylamino)acetamide Hydrochloride_x000b_(Lidocaine Impurity E) 50295-20-0 C13H21ClN2O
ent-Cinacalcet Hydrochloride ent-Cinacalcet Hydrochloride 694495-47-1 C22H22F3N
Nsc529487 Nsc529487 3310-47-2 C9H13N3O6
Oxathiolan 5fu-.B. Oxathiolan 5fu-.B. 145986-11-4 C8H9FN2O4S
Olopatadine Impurity 4 Olopatadine Impurity 4 55690-15-8 C18H18O5
Posaconazole Impurity 26 Posaconazole Impurity 26
Posaconazole Impurity 48 Posaconazole Impurity 48 1902954-03-3 C37H42F2N8O5
Posaconazole Impurity 9 Posaconazole Impurity 9
Roxithromycin Impurity E Roxithromycin Impurity E
SofosBuvir impurity 48 SofosBuvir impurity 48
SofosBuvir Impurity 54 SofosBuvir Impurity 54 1431932-81-8 C12H17ClNO4P
Timolol EP Impurity G Timolol EP Impurity G 75202-36-7 C6H9N3O3S
Tofacitinib Impurity 44 Tofacitinib Impurity 44 2374700-39-5 C13H19N5
Trelagliptin Impurity 24 Trelagliptin Impurity 24
dimethyl 3- isobutylpentanedioate dimethyl 3- isobutylpentanedioate 145328-03-6 C11H20O4
Phenol, 4-chloro-3-[(4-ethoxyphenyl)methyl]- Phenol, 4-chloro-3-[(4-ethoxyphenyl)methyl]- 1408077-50-8 C15H15ClO2
2-amino-9-((3aS,4S,6S,6aR)-3a,6-dihydroxyhexahydro-1H-cyclopenta[c]furan-4-yl)-1,9-dihydro-6H-purin-6-one 2-amino-9-((3aS,4S,6S,6aR)-3a,6-dihydroxyhexahydro-1H-cyclopenta[c]furan-4-yl)-1,9-dihydro-6H-purin-6-one 1984788-96-6 C12H15N5O4
Ampicillin Impurity C Ampicillin Impurity C
Ampicillin Impurity O Ampicillin Impurity O
mixture of PD 312236 and PD 312237 mixture of PD 312236 and PD 312237
Axitinib Impurity 27 Axitinib Impurity 27 1639137-80-6 C24H20N4O2S
(4R,5R,6S)-4-nitrobenzyl 6-((R)-1-hydroxyethyl)-4-methyl-3,7-dioxo-1-azabicyclo[3.2.0]heptane-2-carboxylate (4R,5R,6S)-4-nitrobenzyl 6-((R)-1-hydroxyethyl)-4-methyl-3,7-dioxo-1-azabicyclo[3.2.0]heptane-2-carboxylate 104873-15-6 C17H18N2O7
Lesinurad Impurity Lesinurad Impurity
Chrysophanol triglucoside Chrysophanol triglucoside 120181-07-9 C33H40O19
7H-Pyrazolo[4,3-d]pyrimidin-7-one, 5-(5-chloro-2-ethoxyphenyl)-1,6-dihydro-1-methyl-3-propyl- 7H-Pyrazolo[4,3-d]pyrimidin-7-one, 5-(5-chloro-2-ethoxyphenyl)-1,6-dihydro-1-methyl-3-propyl- 1829588-57-9 C17H19ClN4O2
Cefminox sodium impurities Ⅲ Cefminox sodium impurities Ⅲ
Canagliflozin Impurity 18 Canagliflozin Impurity 18 1951467-29-0 C24H25FO6S
Fosaprepitant Impurity 6 Fosaprepitant Impurity 6 327623-34-7 C21H19F6NO3
Ivabradine Impurity 16 HCl Ivabradine Impurity 16 HCl 304464-98-0 C26H34N2O5
Moxifloxacin EP Impurity A HCl Moxifloxacin EP Impurity A HCl
Paroxetine EP Impurity H HCl Paroxetine EP Impurity H HCl 503834-41-1 C19H23ClFNO
Solifenacin Related Compound 13 Solifenacin Related Compound 13 1251905-45-9 C17H17NO2
1-(3-fluorobenzyl)-1H-pyrazolo[3,4-b]pyridine-3-carboximidamide 1-(3-fluorobenzyl)-1H-pyrazolo[3,4-b]pyridine-3-carboximidamide 2101651-50-5 C14H12FN5
N1-(4-chlorophenyl)-3,12-diimino-N14-phenyl-2,4,11,13-Tetraazatetradecanediimidamide N1-(4-chlorophenyl)-3,12-diimino-N14-phenyl-2,4,11,13-Tetraazatetradecanediimidamide 152504-12-6 C22H31ClN10
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