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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
methyl (4,6-diamino-2-(1-(2-fluorobenzyl)-1H-pyrazolo[3,4-b]
pyridin-3-yl)pyrimidin-5-yl)(ethyl)carbamate methyl (4,6-diamino-2-(1-(2-fluorobenzyl)-1H-pyrazolo[3,4-b] pyridin-3-yl)pyrimidin-5-yl)(ethyl)carbamate 1361570-27-5 C21H21FN8O2
Cefathiamidine Impurity G Cefathiamidine Impurity G
Olaparib Impurity P Olaparib Impurity P
Ozagrel Impurity 1 Ozagrel Impurity 1
Pidotimod Impurity P Pidotimod Impurity P
Pitavastatin Impurity 11 Pitavastatin Impurity 11
Pramipexole Impurity 18 Pramipexole Impurity 18
Tenofovir disoproxil Impurity 18 Tenofovir disoproxil Impurity 18
Tenofovir Impurity 50 Tenofovir Impurity 50
Darunavir Darunavir 1526916-57-3 C22H31N3O5S
(S)-3-(4-(2,5-dibromobenzyl)phenoxy)tetrahydrofuran (S)-3-(4-(2,5-dibromobenzyl)phenoxy)tetrahydrofuran C17H16Br2O2
[4-[2-[(4-chlorobenzoyl)amino]ethyl]phenyl] 4-chlorobenzoate [4-[2-[(4-chlorobenzoyl)amino]ethyl]phenyl] 4-chlorobenzoate 41859-56-7 C22H17Cl2NO3
1-(2,3-Dihydro-1,4-benzodioxin-2-ylcarbonyl)piperazine hydrochloride 1-(2,3-Dihydro-1,4-benzodioxin-2-ylcarbonyl)piperazine hydrochloride 70918-74-0 C13H17ClN2O3
Sugammadex Sugammadex 1378831-29-8 C6H10O3S2
Petunidin 3-O-glucoside Petunidin 3-O-glucoside 71991-88-3 C22H23O12+
N-(2,4-DICHLORO-5-HYDROXYPHENYL)ACETAMIDE N-(2,4-DICHLORO-5-HYDROXYPHENYL)ACETAMIDE 67669-19-6 C8H7Cl2NO2
2-CHLOROMETHYL-3-METHYL-4-(2,2,2-TRIFLUOROETHOXY)PYRIDINE 2-CHLOROMETHYL-3-METHYL-4-(2,2,2-TRIFLUOROETHOXY)PYRIDINE 128430-66-0 C9H9ClF3NO
1-(4-methoxyphenyl)-2-methylpropan-2-ol 1-(4-methoxyphenyl)-2-methylpropan-2-ol 35144-39-9 C11H16O2
4,4'-Iminodiphenol hydrochloride 4,4'-Iminodiphenol hydrochloride 1965310-24-0 C12H12ClNO2
Apalutamide Acid Impurity Apalutamide Acid Impurity 1332391-04-4 C20H12F4N4O3S
Cefradine Impurity D Cefradine Impurity D
(E)-2-(7-methoxy-3,4-dihydronaphthalen-1(2H)-ylidene)ethan-1-amine (E)-2-(7-methoxy-3,4-dihydronaphthalen-1(2H)-ylidene)ethan-1-amine 1371535-54-4 C13H17NO
Donepezil  Impurity Donepezil Impurity 896134-06-8 C17H15NO4
1-(2-chloro-5-(2-fluorophenyl)-1-(pyridin-3-ylsulfonyl)-1H-pyrrol-3-yl)-N-methylmethanamine 1-(2-chloro-5-(2-fluorophenyl)-1-(pyridin-3-ylsulfonyl)-1H-pyrrol-3-yl)-N-methylmethanamine 928325-68-2 C17H15ClFN3O2S
N-methyl-N-(4-nitrophenyl)-2-(piperazin-1-yl)acetamide N-methyl-N-(4-nitrophenyl)-2-(piperazin-1-yl)acetamide 2037385-84-3 C13H19ClN4O3
N-(3,5-dimethylphenyl)picolinamide N-(3,5-dimethylphenyl)picolinamide 439591-67-0 C14H14N2O
Neratinib Impurity  6 Neratinib Impurity 6 1144516-14-2 C26H21ClN6O4
Bupivacaine  Impurity Bupivacaine Impurity 852804-30-9 C22H37N2O
Pseudomonic Acid D Pseudomonic Acid D 85248-93-7 C26H42O9
Terazosin Impurity Terazosin Impurity 60548-08-5 C19H25N5O4
1204612-29-2 1204612-29-2 1204612-29-2 C12H18ClNO2
(S)-3-(dimethylamino)-1-(thiophen-3-yl)propan-1-ol (S)-3-(dimethylamino)-1-(thiophen-3-yl)propan-1-ol 1384080-56-1 C9H15NOS
BDJS-SH 4 BDJS-SH 4 36588-46-2 C12H18N2O2
3-Chloro TirofiBan 3-Chloro TirofiBan 2713130-63-1 C22H35ClN2O5S
Adefovir Dipivoxil Impurity E Adefovir Dipivoxil Impurity E 116384-54-4 C10H16N5O4P
Apixaban Impurity 21 Apixaban Impurity 21
Atorvastatin Impurity 22 Atorvastatin Impurity 22 1821498-27-4 C27H30FNO6
WIXOVOWSUCEDGS-UHFFFAOYSA-N WIXOVOWSUCEDGS-UHFFFAOYSA-N 1346603-05-1 C15H20O5
2-Chloro-1,3-dinitrobenzene 2-Chloro-1,3-dinitrobenzene 606-21-3 C6H3ClN2O4
YXSRVOWUJUXDLJ-UHFFFAOYSA-N YXSRVOWUJUXDLJ-UHFFFAOYSA-N 1618107-97-3 C18H18FNO2S
S-2-Benzothiazolyl-2-amino-±-(methoxyimino)-4-thiazolethiolacetate S-2-Benzothiazolyl-2-amino-±-(methoxyimino)-4-thiazolethiolacetate 1684396-27-7 C13H10N4O2S3
4-[[(1,1-Dimethylethoxy)carbonyl]amino]-2-cyclopentene-1-carboxylic acid methyl ester 4-[[(1,1-Dimethylethoxy)carbonyl]amino]-2-cyclopentene-1-carboxylic acid methyl ester 168683-02-1 C12H19NO4
KNKJEUNXMFFFDU-LZHIOSKDSA-N KNKJEUNXMFFFDU-LZHIOSKDSA-N 138804-88-3 C25H34O6
MONO-DESACETYL FAMCICLOVIR MONO-DESACETYL FAMCICLOVIR 104227-88-5 C12H17N5O3
(E)-5-(2-CARBOXYVINYL)-2'-DEOXYURIDINE (E)-5-(2-CARBOXYVINYL)-2'-DEOXYURIDINE 74131-06-9 C12H14N2O7
HHUBRUYPYDODRB-UHFFFAOYSA-N HHUBRUYPYDODRB-UHFFFAOYSA-N 106860-70-2 C8H5NO5
5-Decyano 5-(Ethyl Formate) Milrinone 5-Decyano 5-(Ethyl Formate) Milrinone 80442-07-5 C14H14N2O3
25-DESACETYL RIFAMPICIN 25-DESACETYL RIFAMPICIN 16783-99-6 C41H56N4O11
ETHYL 2-CYCLOHEXYL-2-HYDROXY-PHENYLACETATE ETHYL 2-CYCLOHEXYL-2-HYDROXY-PHENYLACETATE 31197-69-0 C16H22O3
Apixaban Impurity 33 Apixaban Impurity 33 1686149-78-9 C21H27N3O3
1,8-bis(4-((1,4,8,11-tetraazacyclotetradecan-1-yl)methyl)benzyl)-1,4,8,11-tetraazacyclotetradecane 1,8-bis(4-((1,4,8,11-tetraazacyclotetradecan-1-yl)methyl)benzyl)-1,4,8,11-tetraazacyclotetradecane 414858-02-9 C46H84N12
butyl 3-((3R,4R)-4-methyl-3-(methyl(7H-pyrrolo[2,3-d]pyrimidin-4-yl)amino)piperidin-1-yl)-3-oxopropanoate butyl 3-((3R,4R)-4-methyl-3-(methyl(7H-pyrrolo[2,3-d]pyrimidin-4-yl)amino)piperidin-1-yl)-3-oxopropanoate 2227199-31-5 C20H29N5O3
ethyl 2-((E)-5-((E)-2-methyl-3-phenylallylidene)-4-oxo-2-thioxothiazolidin-3-yl)acetate ethyl 2-((E)-5-((E)-2-methyl-3-phenylallylidene)-4-oxo-2-thioxothiazolidin-3-yl)acetate 682775-71-9 C17H17NO3S2
Ethyl 4-hydroxy-2-methyl-2H-1,2-benzothiazine-3-carboxylate 1,1-dioxide Ethyl 4-hydroxy-2-methyl-2H-1,2-benzothiazine-3-carboxylate 1,1-dioxide 24683-26-9 C12H13NO5S
Azelastine EP Impurity E Azelastine EP Impurity E 105279-16-1 C15H9ClO2
Blonanserin impurity F Blonanserin impurity F
Capecitabine Impurity 9 Capecitabine Impurity 9
Carfilzomib Impurity E Carfilzomib Impurity E
Cefoxitin EP Impurity B Cefoxitin EP Impurity B
Dabigatran Impurity 3 Dabigatran Impurity 3
Dexamethasone EP Impurity K Dexamethasone EP Impurity K 1809224-82-5 C22H26O4
Esomeprazole Impurity 3 Esomeprazole Impurity 3 1346599-85-6 C26H30N4O4S
FeBuxostat Impurity 41 FeBuxostat Impurity 41 2428631-67-6 C19H19N3O3S
Formoterol EP Impurity E Formoterol EP Impurity E 1616967-26-0 C20H26N2O4
Formoterol Impurity 16 Formoterol Impurity 16
Indacaterol Impurity 11 Indacaterol Impurity 11
Isavuconazole Impurity 14 Isavuconazole Impurity 14
Isavuconazole Impurity 19 Isavuconazole Impurity 19
Isavuconazole Impurity 24 Isavuconazole Impurity 24 1176988-44-5 C22H17F2N5OS
Letrozole Impurity 10 Letrozole Impurity 10
Levofloxacin Impurity 9 Levofloxacin Impurity 9 1797099-76-3 C18H20FN3O4
N-(5-Formyl-2-hydroxyphenyl)formamide N-(5-Formyl-2-hydroxyphenyl)formamide 903563-43-9 C8H7NO3
Nitrendipine Impurity 5 Nitrendipine Impurity 5
Posaconazole Impurity 32 Posaconazole Impurity 32
Posaconazole Impurity 61 Posaconazole Impurity 61
Procaterol Impurity 4 Procaterol Impurity 4 63235-39-2 C16H20N2O3
Sitagliptin Impurity 14 Sitagliptin Impurity 14 2072867-07-1 C26H23F9N6O2
SofosBuvir Impurity 31 SofosBuvir Impurity 31
sofosBuvir Impurity 37 sofosBuvir Impurity 37
SofosBuvir Impurity 53 SofosBuvir Impurity 53 1015255-46-5 C20H25FN3O9P
Sofosbuvir Impurity 60 Sofosbuvir Impurity 60
Tenofovir impurity G Tenofovir impurity G
Ticagrelor Impurity 26 Ticagrelor Impurity 26 2245167-79-5 C21H24F2N6O3S
Vildagliptin Impurity 19 Vildagliptin Impurity 19 243145-00-8 C10H16N2O2
Olopatadine Isopropyl ester Hydrochloride Olopatadine Isopropyl ester Hydrochloride 1206456-44-1 C24H29NO3
GLATIRAMER impurity GLATIRAMER impurity
Amoxicillin Impurity  U Amoxicillin Impurity U C16H19N3O5S
Amoxicillin Impurity  U Amoxicillin Impurity U C16H19N3O5S
Oxacillin Sodium Impurity I(EP) Oxacillin Sodium Impurity I(EP)
Spectinomycin Impurity E Spectinomycin Impurity E
3-butyl-3-hydroxy-2-benzofuran-1-one 3-butyl-3-hydroxy-2-benzofuran-1-one 162050-42-2 C12H14O3
(4S,4aS,5aR,12aS)-4,7-bis(dimethylamino)-3,10,12,12a-tetrahydroxy-1,11-dioxo-1,4,4a,5,5a,6,11,12a-octahydrotetracene-2-carboxamide (minocycline) (4S,4aS,5aR,12aS)-4,7-bis(dimethylamino)-3,10,12,12a-tetrahydroxy-1,11-dioxo-1,4,4a,5,5a,6,11,12a-octahydrotetracene-2-carboxamide (minocycline)
(R)-10-(2,4,5-trifluorobenzyl)-3-(trifluoromethyl)-6,7,10,11-tetrahydro-[1,2,4]triazolo[3,4-c][1,4,7]triazecine-8,12(5H,9H)-dione (R)-10-(2,4,5-trifluorobenzyl)-3-(trifluoromethyl)-6,7,10,11-tetrahydro-[1,2,4]triazolo[3,4-c][1,4,7]triazecine-8,12(5H,9H)-dione 2088771-61-1 C16H13F6N5O2
N-((3R,4S)-1-benzyl-4-methylpiperidin-3-yl)-N-methyl-7H-pyrrolo[2,3-d]pyrimidin-4-amine N-((3R,4S)-1-benzyl-4-methylpiperidin-3-yl)-N-methyl-7H-pyrrolo[2,3-d]pyrimidin-4-amine 1092578-45-4 C20H25N5
846023-56-1 846023-56-1 846023-56-1 C26H31Cl2N5O4
Prednisone impurity D (EP) Prednisone impurity D (EP) 10184-69-7 C21H26O4
Lisinopril EP Impurity G Lisinopril EP Impurity G 1356839-89-8 C42H60N6O9
2-hexanoylbenzoic acid 2-hexanoylbenzoic acid 857538-11-5 C13H16O3
Blonanserin N-Oxide Blonanserin N-Oxide 142838-82-2 C23H30FN3O
Levofloxacin Impurity 11 Levofloxacin Impurity 11 106939-42-8 C9H9F2NO
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