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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
1-Pentanone, 1-(2-hydroxy-5-methylphenyl)- 1-Pentanone, 1-(2-hydroxy-5-methylphenyl)- 150033-77-5 C12H16O2
3-methyl-2-pentylphenol 3-methyl-2-pentylphenol 1823068-39-8 C12H18O
PLSQ-001 TM4-QJ PLSQ-001 TM4-QJ 1227162-74-4 C18H24N2O2
(2S)-2-(2,5-dioxo-3-propylpyrrolidin-1-yl)butanoic acid (2S)-2-(2,5-dioxo-3-propylpyrrolidin-1-yl)butanoic acid 2101641-92-1 C11H17NO4
2-Pyridineethanamine, N-methyl-N-[2-(2-pyridinyl)ethyl]-, hydrochloride (1:3) 2-Pyridineethanamine, N-methyl-N-[2-(2-pyridinyl)ethyl]-, hydrochloride (1:3) 2095467-43-7 C15H20ClN3
(S)-tert-butyl (1-(3-(2-cyanobenzyl) (S)-tert-butyl (1-(3-(2-cyanobenzyl) 1618644-31-7 C23H29N5O4
(S)-tert-butyl (1-(3-(2-cyanobenzyl) (S)-tert-butyl (1-(3-(2-cyanobenzyl) 1618644-31-7 C23H29N5O4
Droxidopa Impurity 4 Droxidopa Impurity 4 55382-14-4 C31H29NO7
RV Salmonella enrichment broth (Pharmacopoeia 2015 edition) RV Salmonella enrichment broth (Pharmacopoeia 2015 edition)
(1r,4r)-4-(5,6-dibromo-2-methylquinazolin-3(4H)-yl)cyclohexan-1-ol (1r,4r)-4-(5,6-dibromo-2-methylquinazolin-3(4H)-yl)cyclohexan-1-ol
N-(5-(Propionyloxy)pentyl Acrylate) rac-trans-Laudanosine Benzenesulfonate N-(5-(Propionyloxy)pentyl Acrylate) rac-trans-Laudanosine Benzenesulfonate 155913-32-9 C38H49NO11S
1,8-ditosyl-1,4,8,11-tetraazacyclotetradecane dihydrochloride 1,8-ditosyl-1,4,8,11-tetraazacyclotetradecane dihydrochloride C24H38Cl2N4O4S2
Mupirocin iMpurity 5 Mupirocin iMpurity 5 C26H44O9
Tolvaptan Impurity 11 Tolvaptan Impurity 11 150683-27-5 C25H23ClN2O3
methyl 2-(4-(2-chloroacetyl)phenyl)-2-methylpropanoate methyl 2-(4-(2-chloroacetyl)phenyl)-2-methylpropanoate 1638785-19-9 C13H15ClO3
1155863-81-2 1155863-81-2 1155863-81-2 C23H19F2N3O6
1175018-73-1 1175018-73-1 1175018-73-1 C12H14ClN
tert-butyl (3S,5R)-7-(2-(4-fluorophenyl)-5-isopropyl-3-phenyl-4- (phenylcarbamoyl)-1H-pyrrol-1-yl)-3,5-dihydroxyheptanoate tert-butyl (3S,5R)-7-(2-(4-fluorophenyl)-5-isopropyl-3-phenyl-4- (phenylcarbamoyl)-1H-pyrrol-1-yl)-3,5-dihydroxyheptanoate C37H43FN2O5
Nitrendipine iMpurity 3 Nitrendipine iMpurity 3
Cefminox Impurity 3 Cefminox Impurity 3
Afatinib Impurity 57 Afatinib Impurity 57
Afatinib Impurity 57 Afatinib Impurity 57
Apremilast Impurity 34 Apremilast Impurity 34 2469037-82-7 C20H20N2O7S
Aprepitant Impurity 35 Aprepitant Impurity 35
Bosutinib Impurity 15 Bosutinib Impurity 15
Ertapenem Impurity 2 Ertapenem Impurity 2
Febuxostat Impurity 68 Febuxostat Impurity 68
Indacaterol Impurity 9 Indacaterol Impurity 9
Olanzapine Impurity 22 Olanzapine Impurity 22 C17H20N4S
Olopatadine Impurity 9 Olopatadine Impurity 9 680579-52-6 C39H36Br2P2
Clopidogrel Impurity 44 Clopidogrel Impurity 44 C15H14ClNO2S
5-ethyl 7-methyl 6-(2-chlorophenyl)-8-methyl-3,4,5,6-tetrahydro-2H- benzo[b][1,4]oxazine-5,7-dicarboxylate 5-ethyl 7-methyl 6-(2-chlorophenyl)-8-methyl-3,4,5,6-tetrahydro-2H- benzo[b][1,4]oxazine-5,7-dicarboxylate 949155-13-9 C20H22ClNO5
Nifedipine impurity 06 Nifedipine impurity 06 C19H22N2O6
Moxifloxacin Impurity 10 Moxifloxacin Impurity 10
Ticagrelor Impurity 11 Ticagrelor Impurity 11
Parecoxib Impurity 18 Parecoxib Impurity 18
Apixaban Impurity 34 Apixaban Impurity 34
Teneligliptin Impurity 9 DiHCl Teneligliptin Impurity 9 DiHCl
Pramipexole Impurity Z2 Pramipexole Impurity Z2
monocalciummono(4-(((2R,4R)-1-([1,1'-biphenyl]-4-yl)-5-ethoxy- 4-methyl-5-oxopentan-2-yl)amino)-4-oxobutanoate) monocalciummono(4-(((2R,4R)-1-([1,1'-biphenyl]-4-yl)-5-ethoxy- 4-methyl-5-oxopentan-2-yl)amino)-4-oxobutanoate) C24H28CaNO5
Aprepitant iMpurity 40 Aprepitant iMpurity 40
Aprepitant iMpurity43 Aprepitant iMpurity43
1-Propanamine, 3-(diphenylphosphinyl)-N,N-dimethyl- 1-Propanamine, 3-(diphenylphosphinyl)-N,N-dimethyl- 962-95-8 C17H22NOP
Afatinib Impurity ODQ Afatinib Impurity ODQ
Afatinib Impurity ODQ Afatinib Impurity ODQ
Afatinib Impurity QJJ Afatinib Impurity QJJ 2323570-72-3 C24H27ClFN5O4
Afatinib Impurity QJJ Afatinib Impurity QJJ 2323570-72-3 C24H27ClFN5O4
Cabozantinib Impurity 50 Cabozantinib Impurity 50 202917-05-3 C17H14N2O5
Landiolol impurity U Landiolol impurity U
Teneligliptin Impurity 15 Teneligliptin Impurity 15
Nicergoline EP Impurity I Nicergoline EP Impurity I
Carbamic acid, N-[(4-methylphenyl)sulfonyl]- Carbamic acid, N-[(4-methylphenyl)sulfonyl]- 107628-27-3 C8H9NO4S
9H-Purin-6-amine, 9-(2-chloropropyl)- 9H-Purin-6-amine, 9-(2-chloropropyl)- 50615-40-2 C8H10ClN5
Hyoscine Butylbromide EP Impurity G Hyoscine Butylbromide EP Impurity G
tirofiban Impurity 1 DIHCl tirofiban Impurity 1 DIHCl
Fingolimod 2-Phenethyl Analog Fingolimod 2-Phenethyl Analog 851039-25-3 C35H57NO2
Ritonavir EP Impurity O Ritonavir EP Impurity O 1414933-81-5 C37H48N6O5S2
Entecavir Impurity 17(Entecavir EP Impurity C) Entecavir Impurity 17(Entecavir EP Impurity C) 2204369-23-1 C12H15N5O4
Gemcitabine Impurity 9 Gemcitabine Impurity 9 2174019-90-8 C16H15F2N3O5
Sacubitril Sacubitril 1361408-17-4 C18H20ClNO2
Empagliflozin Impurity 43 Empagliflozin Impurity 43
1-tosyl-1,4,8,11-tetraazacyclotetradecane trihydrochloride 1-tosyl-1,4,8,11-tetraazacyclotetradecane trihydrochloride 128495-30-7 C17H31ClN4O2S
Oseltamivir Impurity 59 Oseltamivir Impurity 59 2485836-60-8 C12H22N2O3
Palbociclib Impurity 36 Palbociclib Impurity 36
Regorafenib Impurity 34 Regorafenib Impurity 34
Rosuvastatin Impurity 47 Rosuvastatin Impurity 47
Sildenafil Impurity 36 Sildenafil Impurity 36 C25H27N3O5
Sunitinib Impurity 4 Sunitinib Impurity 4
Tafluprost Impurity 11 Tafluprost Impurity 11
Tazobactam Impurity 4 Tazobactam Impurity 4
Ticagrelor Impurity 103 Ticagrelor Impurity 103
Ticagrelor Impurity 94 Ticagrelor Impurity 94
Tofacitinib Impurity 119 Tofacitinib Impurity 119
Trelagliptin Impurity 26 Trelagliptin Impurity 26
Trelagliptin Impurity 31 Trelagliptin Impurity 31
Caspofungin impurity E Caspofungin impurity E
Erythromycin Impurity C Erythromycin Impurity C
Itraconazole iMpurity 4 Itraconazole iMpurity 4
Azacitidine Impurity 3 Azacitidine Impurity 3
Ozagrel Impurity 2 Ozagrel Impurity 2
Olaparib Impurity 22 Olaparib Impurity 22
Irbesartan Impurity 14 Irbesartan Impurity 14 133690-91-2 C25H28N6O
Febuxostat Impurity 25 Febuxostat Impurity 25 1643131-89-8 C17H20N2O4S
Pregabalin Impurity 3 Pregabalin Impurity 3 1928754-83-9 C12H22O3
Bosutinib Impurity 6 Bosutinib Impurity 6
Ticagrelor Impurity 49 Ticagrelor Impurity 49 2376278-80-5
Edoxaban Impurity 14 Edoxaban Impurity 14
Indacaterol Impurity 3 Indacaterol Impurity 3 2250243-41-3 C26H32N2O3
Canagliflozin Impurity 11 Canagliflozin Impurity 11
Oseltamivir Impurity 22 Oseltamivir Impurity 22
Riociguat IMpurtiy B Riociguat IMpurtiy B
Amlodipine Impurity 48 Amlodipine Impurity 48 39562-06-6 C18H20ClNO4
Silodosin Impurity C Silodosin Impurity C
Dexmedetomidine-025 Dexmedetomidine-025 2250242-52-3 C20H22N2
pranoprofen impurity 15 pranoprofen impurity 15
Mono-Hydroxy Sugammadex Mono-Hydroxy Sugammadex 2376607-99-5 C69H109NaO47S7
Metronidazole impurity A Metronidazole impurity A
Sulpiride Impurity 6 Sulpiride Impurity 6
Cefminox Impurity A Cefminox Impurity A
Cefminox Impurity F Cefminox Impurity F
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