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
Regorafenib impurity D Regorafenib impurity D
SofosBuvir impurity 21 SofosBuvir impurity 21 1496552-50-1 C22H29ClN3O9P
sofosBuvir impurity 36 sofosBuvir impurity 36
SofosBuvir Impurity 52 SofosBuvir Impurity 52
SofosBuvir Impurity 59 SofosBuvir Impurity 59
Ticagrelor impurity 25 Ticagrelor impurity 25
Tirofiban Impurity 14 Tirofiban Impurity 14 1103300-75-9 C12H17NO5S
Tirofiban Impurity 19 Tirofiban Impurity 19 158808-75-4 C18H28N2O3
Entacapone Entacapone
nifedipine iMpurity nifedipine iMpurity C19H22N2O6
Linagliptin Impurity A Linagliptin Impurity A
Dehydropitavastatin ethyl ester Dehydropitavastatin ethyl ester 254452-91-0 C27H26FNO4
(S)-2-(2-oxo-4-propyl-2,5-dihydro-1H-pyrrol-1-yl)butanamide (S)-2-(2-oxo-4-propyl-2,5-dihydro-1H-pyrrol-1-yl)butanamide 357338-13-7 C11H18N2O2
Linagliptin Impurity V Linagliptin Impurity V
methyl 2-(4-(2-chloroethyl)phenyl)-2-methylpropanoate methyl 2-(4-(2-chloroethyl)phenyl)-2-methylpropanoate 1181267-33-3 C13H17ClO2
(2RS)-1-bromo-2-(2,4-difluorophenyl)-3-(1H-1,2,4-triazol-1-yl)propan-2-ol (2RS)-1-bromo-2-(2,4-difluorophenyl)-3-(1H-1,2,4-triazol-1-yl)propan-2-ol 150194-52-8 C11H10BrF2N3O
(S)-2-(((1R,2S,5S)-2-(2-((5-chloropyridin-2-yl)amino)-2-oxoacetamido)-5-(dimethylcarbamoyl)cyclohexyl)carbamoyl)-5-methyl-4,5,6,7-tetrahydrothiazolo[5,4-c]pyridine 5-oxide (S)-2-(((1R,2S,5S)-2-(2-((5-chloropyridin-2-yl)amino)-2-oxoacetamido)-5-(dimethylcarbamoyl)cyclohexyl)carbamoyl)-5-methyl-4,5,6,7-tetrahydrothiazolo[5,4-c]pyridine 5-oxide C24H30ClN7O5S
Etoricoxib Impurity 18 Etoricoxib Impurity 18
Ibrutinib Impurity 4 Ibrutinib Impurity 4 1807619-68-6 C17H12ClN5O
Imatinib Impurity 3 Imatinib Impurity 3
Mirabegron Impurity 16 Mirabegron Impurity 16
Olaparib Impurity 2 Olaparib Impurity 2
Sofosbuvir Impurity 7 Sofosbuvir Impurity 7 1884385-12-9 C20H19FO6
Vonoprazan Impurity 3 Vonoprazan Impurity 3 928325-41-1 C17H15F2N3O2S
Cinacalcet Impurity 22 Cinacalcet Impurity 22
Dapagliflozin Impurity C Dapagliflozin Impurity C
Dasatinib Impurity E Dasatinib Impurity E
Ixazomib Impurity Ixazomib Impurity
Nevirapine Impurity Nevirapine Impurity
Omarigliptin Impurity Omarigliptin Impurity 1819364-01-6 C16H18F2N4O
Palbociclib Impurity 8 Palbociclib Impurity 8 827022-31-1 C31H41N7O4
Sitagliptin EP Impurity C Sitagliptin EP Impurity C 1345822-86-7 C16H19F5N5O5P
Trifluridine Impurity Trifluridine Impurity 2086328-10-9
Valsartan related compound H Valsartan related compound H
Vildagliptin Related Compound H Vildagliptin Related Compound H 2253194-13-5 C12H16N4O
Moxifloxacin Impurity 7 Moxifloxacin Impurity 7
(R)-6-Benzyloxy-8-(oxiran-2-yl)-4H-benzo[1,4]oxazin-3-one (R)-6-Benzyloxy-8-(oxiran-2-yl)-4H-benzo[1,4]oxazin-3-one 869478-12-6 C17H15NO4
Merariveron impurity D Merariveron impurity D C26H28N6O3S2
Cefazolin impurity E Cefazolin impurity E
Lamivudine Impurity Mixture Lamivudine Impurity Mixture
Rifaximin impurity B Rifaximin impurity B 1351775-04-6 C43H49N3O11
4-(3-(Piperidin-1-yl)propoxy)benzoic acid 4-(3-(Piperidin-1-yl)propoxy)benzoic acid 767286-87-3 C15H21NO3
1,2-Ethanediamine, N,N,N',N'-tetrakis(2-aminoethyl)- 1,2-Ethanediamine, N,N,N',N'-tetrakis(2-aminoethyl)- 4097-90-9 C10H28N6
Omeprazole EP Impurity G Omeprazole EP Impurity G 125656-83-9 C16H13N3O2S
Piperazine, 1-methyl-4-[(4-methyl-1-piperazinyl)carbonyl]- Piperazine, 1-methyl-4-[(4-methyl-1-piperazinyl)carbonyl]- 4180-30-7 C11H22N4O
Amoxicillin Impurity  P Amoxicillin Impurity P C16H19N3O5S
Ampicillin Impurity S Ampicillin Impurity S
Cefdinir Impurity F (CP) Cefdinir Impurity F (CP)
6-methyl-2-oxo-5-pyridin-2-yl-1H-pyridine-3-carbonitrile 6-methyl-2-oxo-5-pyridin-2-yl-1H-pyridine-3-carbonitrile 106637-42-7 C12H9N3O
Levofloxacin Impurity 15 Levofloxacin Impurity 15 94714-58-6 C14H12F4O4
Losartan Impurity 2 Losartan Impurity 2 1407521-00-9 C22H20ClN3O
Epoxy Exemestane (6-Alfa Isomer) Epoxy Exemestane (6-Alfa Isomer) 152764-24-4 C20H24O3
6-Cyclopropyl-10-fluoro-7,8-dihydrobenzo[k]phenanthridine 6-Cyclopropyl-10-fluoro-7,8-dihydrobenzo[k]phenanthridine 1187966-94-4 C20H16FN
2-CHLORO-N-(2,5-DIMETHYLPHENYL)ACETAMIDE 2-CHLORO-N-(2,5-DIMETHYLPHENYL)ACETAMIDE 5177-35-5 C10H12ClNO
alpha-(Dimethylaminomethyl)-alpha-ethylbenzyl alcohol hydrochloride alpha-(Dimethylaminomethyl)-alpha-ethylbenzyl alcohol hydrochloride 104743-23-9 C12H20ClNO
Donepezil Impurity 3 Donepezil Impurity 3 1023500-88-0 C24H27NO4
Fesoterodine Related Impurity 4 Fesoterodine Related Impurity 4 214601-12-4 C22H29NO2
Prasugrel Impurity 14 Maleate Prasugrel Impurity 14 Maleate 1373350-60-7 C24H25BrFNO7S
Sofosbuvir Impurity 32 Sofosbuvir Impurity 32 1157884-58-6 C20H17FO6
Torsemide Related Compound 1 Torsemide Related Compound 1 947327-54-0 C13H13N3O2S
Vortioxetine Impurity 3 Vortioxetine Impurity 3 508233-82-7 C17H20N2S
CYCLOPENTYL BENZOATE CYCLOPENTYL BENZOATE 32651-38-0 C12H14O2
Flucloxacillin Sodium Impurity A Flucloxacillin Sodium Impurity A 68728-50-7 C19H20ClFN3NaO6S
Oxacillin Sodium Impurity G(EP) Oxacillin Sodium Impurity G(EP) 724695-30-1 C19H18ClN3O5S
Spectinomycin Impurity D Spectinomycin Impurity D
(4R,4aS,5aR,12aS)-9-[2-(tert-butylamino)acetamido]-4,7-bis(dimethylamino)-3,10,12,12a-tetrahydroxy-1,11-dioxo-1,4,4a,5,5a,6,11,12a-octahydrotetracene-2-carboxamide (4R,4aS,5aR,12aS)-9-[2-(tert-butylamino)acetamido]-4,7-bis(dimethylamino)-3,10,12,12a-tetrahydroxy-1,11-dioxo-1,4,4a,5,5a,6,11,12a-octahydrotetracene-2-carboxamide C29H39N5O8
Amifostine Impurity 3 Amifostine Impurity 3 41510-53-6 C5H15N2O3PS
Cefradine impurity C Cefradine impurity C
Cefuroxime sodium impurity H Cefuroxime sodium impurity H C16H16N4NaO8S
Bilastine N-Oxide Bilastine N-Oxide 2069238-47-5 C28H37N3O4
Cefoxitin impurity F Cefoxitin impurity F
Tenofovir Disoproxil Fumarate impurity N Tenofovir Disoproxil Fumarate impurity N 1962114-92-6 C29H44N10O14P2
Prednisolone Impurity 7 Prednisolone Impurity 7 61549-70-0 C21H26O6
Tenofovir Related Compound 10 Tenofovir Related Compound 10 16958-60-4 C8H11N5O
N-(4-methyl-3-(N-(4-(pyridin-3-yl)pyrimidin-2-yl)acetamido)phenyl)-4-((4-methylpiperazin-1-yl)methyl)benzamide N-(4-methyl-3-(N-(4-(pyridin-3-yl)pyrimidin-2-yl)acetamido)phenyl)-4-((4-methylpiperazin-1-yl)methyl)benzamide C31H33N7O2
N1-benzyl-N1,4-dimethyl-N3-(4-(pyridin-3-yl)pyrimidin-2-yl)benzene-1,3-diamine N1-benzyl-N1,4-dimethyl-N3-(4-(pyridin-3-yl)pyrimidin-2-yl)benzene-1,3-diamine C24H23N5
(E)-4-(((5-(2-fluorophenyl)-1-(pyridin-3-ylsulfonyl)-1H-pyrrol-3- yl)methyl)(methyl)amino)-4-oxobut-2-enoic acid (E)-4-(((5-(2-fluorophenyl)-1-(pyridin-3-ylsulfonyl)-1H-pyrrol-3- yl)methyl)(methyl)amino)-4-oxobut-2-enoic acid C21H18FN3O5S
Apremilast Apremilast 1384439-80-8 C17H16N2O6S
TROXACITABINE TROXACITABINE 145511-98-4 C8H11N3O4
XXZJUZXKBFUPQH-IKGGRYGDSA-N XXZJUZXKBFUPQH-IKGGRYGDSA-N 1618657-31-0 C18H17FO4
2-methoxy-1,7,9-trimethylpurine-6,8-dione 2-methoxy-1,7,9-trimethylpurine-6,8-dione 51168-26-4 C9H12N4O3
(+/-)-tert-Butyl 6-Chloro-5-hydroxy-3-oxohexanoate (+/-)-tert-Butyl 6-Chloro-5-hydroxy-3-oxohexanoate 319924-73-7 C10H17ClO4
(R)-2-(2-aminothiazol-4-yl)-N-(2-(2-((2-hydroxy-2-phenylethyl)amino)ethyl)phenyl)acetamide (R)-2-(2-aminothiazol-4-yl)-N-(2-(2-((2-hydroxy-2-phenylethyl)amino)ethyl)phenyl)acetamide 1684452-80-9 C21H24N4O2S
1,4-Dihydro-2,6-dimethyl-4-(3-nitrophenyl)-3,5-pyridinedicarboxylic Acid 3-[2-[(3,3-Diphenylpropyl)methylamino]-1,1-dimethylethyl] 5-ethyl Ester Hydrochloride 1,4-Dihydro-2,6-dimethyl-4-(3-nitrophenyl)-3,5-pyridinedicarboxylic Acid 3-[2-[(3,3-Diphenylpropyl)methylamino]-1,1-dimethylethyl] 5-ethyl Ester Hydrochloride 210579-71-8 C37H44ClN3O6
2-chloro-5-(2-fluorophenyl)-1H-pyrrole-3-carbaldehyde 2-chloro-5-(2-fluorophenyl)-1H-pyrrole-3-carbaldehyde 2169267-53-0 C11H7ClFNO
4-(4-(4-(4-(((3S,5S)-5-((1H-1,2,4-triazol-1-yl)methyl)-5-(2,4-difluorophenyl)tetrahydrofuran-3-yl)methoxy)phenyl)piperazin-1-yl)phenyl)-1-((2R,3S)-2-hydroxypentan-3-yl)-1H-1,2,4-triazol-5(4H)-one 4-(4-(4-(4-(((3S,5S)-5-((1H-1,2,4-triazol-1-yl)methyl)-5-(2,4-difluorophenyl)tetrahydrofuran-3-yl)methoxy)phenyl)piperazin-1-yl)phenyl)-1-((2R,3S)-2-hydroxypentan-3-yl)-1H-1,2,4-triazol-5(4H)-one 2243785-99-9 C37H42F2N8O4
5-(2-fluorophenyl)-N-methyl-1-(pyridin-3-ylsulfonyl)-1H-pyrrole-3-carboxamide 5-(2-fluorophenyl)-N-methyl-1-(pyridin-3-ylsulfonyl)-1H-pyrrole-3-carboxamide 2054536-04-6 C17H14FN3O3S
Ozagrel Impurity 10 Ozagrel Impurity 10
tris((5-(2-fluorophenyl)-1H-pyrrol-3-yl)methyl)amine tris((5-(2-fluorophenyl)-1H-pyrrol-3-yl)methyl)amine C33H27F3N4
Esmolol impurity C Esmolol impurity C
(R)-(+)-(3-CHLORO-2-HYDROXYPROPYL)TRIMETHYLAMMONIUM CHLORIDE (R)-(+)-(3-CHLORO-2-HYDROXYPROPYL)TRIMETHYLAMMONIUM CHLORIDE 117604-42-9 C6H15Cl2NO
REICHSTEIN'S SUBSTANCE S 21-ACETATE REICHSTEIN'S SUBSTANCE S 21-ACETATE 640-87-9 C23H32O5
N,N'-(OXYDI-4,1-PHENYLENE)BISACETAMIDE N,N'-(OXYDI-4,1-PHENYLENE)BISACETAMIDE 3070-86-8 C16H16N2O3
3-(2-hydroxyethyl) 5-methyl 2,6-dimethyl-4-(3-nitrophenyl)-1,4-dihydropyridine-3,5-dicarboxylate 3-(2-hydroxyethyl) 5-methyl 2,6-dimethyl-4-(3-nitrophenyl)-1,4-dihydropyridine-3,5-dicarboxylate 85677-95-8 C18H20N2O7
3-isobutylisobenzofuran-1(3H)-one 3-isobutylisobenzofuran-1(3H)-one 199736-94-2 C12H14O2
isopropyl(4,6-diamino-2-(1-(2-fluorobenzyl)-1H-pyrazolo[3,4-b]
pyridin-3-yl)pyrimidin-5-yl)(methyl)carbamate isopropyl(4,6-diamino-2-(1-(2-fluorobenzyl)-1H-pyrazolo[3,4-b] pyridin-3-yl)pyrimidin-5-yl)(methyl)carbamate 625115-54-0 C22H23FN8O2
Malvidin 3-O-glucoside Malvidin 3-O-glucoside 18470-06-9 C23H25O12+
6-Hydroxyluteolin 7-glucoside 6-Hydroxyluteolin 7-glucoside 54300-65-1 C21H20O12
(S)-Olodaterol (S)-Olodaterol 868049-50-7 C21H26N2O5
5,6-DIHYDRO-3-METHYLAMINO-2H-1,4-THIAZIN-2-ONE OXIME 5,6-DIHYDRO-3-METHYLAMINO-2H-1,4-THIAZIN-2-ONE OXIME 148639-72-9 C5H9N3OS
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