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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
1,4-bis(4-((1,4,8,11-tetraazacyclotetradecan-4,8,11-trifluoroacetyl- 1-yl)methyl)benzyl)-8,11-difluoroacetyl-1,4,8,11-tetraazacyclotetra decane 1,4-bis(4-((1,4,8,11-tetraazacyclotetradecan-4,8,11-trifluoroacetyl- 1-yl)methyl)benzyl)-8,11-difluoroacetyl-1,4,8,11-tetraazacyclotetra decane
Imidafenacin Related Compound 10 Imidafenacin Related Compound 10 212756-27-9 C21H23N3O
Aprepitant Aprepitant 1242175-36-5 C20H18F7NO2
Idebenone Impurity 5 Idebenone Impurity 5 88543-33-3 C18H28O5
Entacapone Impurity 4 Entacapone Impurity 4 1202160-40-4 C11H8N2O6
L-Leucine, N-formyl-, (1S)-1-[[(2S,3S)-3-hexyl-4-oxo-2-oxetanyl]methyl]tridecyl ester L-Leucine, N-formyl-, (1S)-1-[[(2S,3S)-3-hexyl-4-oxo-2-oxetanyl]methyl]tridecyl ester 1119226-56-0 C30H55NO5
Itraconazole Impurity 17 Itraconazole Impurity 17 854372-78-4 C14H15Cl2N3O5S
sodium (41S,12R,13aS)-13a-ethyl-12-hydroxy-2,3,41,5,6,12, 13,13a-octahydro-1H-indolo[3,2,1-de]pyrido[3,2,1-ij][1,5] naphthyridine-12-carboxylate sodium (41S,12R,13aS)-13a-ethyl-12-hydroxy-2,3,41,5,6,12, 13,13a-octahydro-1H-indolo[3,2,1-de]pyrido[3,2,1-ij][1,5] naphthyridine-12-carboxylate 53448-45-6 C20H24N2O3
Rivaroxaban Impurity 35 Rivaroxaban Impurity 35 2206360-74-7 C23H24N4O6
Tirofiban hydrochloride monohydrate Impurity 7 Tirofiban hydrochloride monohydrate Impurity 7 2250244-28-9 C13H19NO5S
Acarbose Impurity G Acarbose Impurity G
Imidafenacin Related Compound 7 Imidafenacin Related Compound 7 191592-57-1 C16H13N
17β-Cyanmethyl-oestra-1,3,5(10)-trien-3,17β-diol 17β-Cyanmethyl-oestra-1,3,5(10)-trien-3,17β-diol 16669-06-0 C20H25NO2
Cefaclor Impurity 6 Cefaclor Impurity 6
Cephalexin Impurity 6 Cephalexin Impurity 6 C16H17N3O4S
Pitavastatin Impurity 42 Pitavastatin Impurity 42
Rocuronium bromide Impurity J Rocuronium bromide Impurity J C32H53BrN2O4
Tofacitinib Impurity 72 Tofacitinib Impurity 72
3-[[4-[2-(2H-tetrazol-5-yl)phenyl]phenyl]methyl]-2-[1-[4-[2-(2H-tetrazol-5-yl)phenyl]phenyl]pentan-2-yl]-1,3-diazaspiro[4.4]non-1-en-4-one 3-[[4-[2-(2H-tetrazol-5-yl)phenyl]phenyl]methyl]-2-[1-[4-[2-(2H-tetrazol-5-yl)phenyl]phenyl]pentan-2-yl]-1,3-diazaspiro[4.4]non-1-en-4-one 1346598-52-4 C39H38N10O
3-HYDROXY-THIOBENZAMIDE 3-HYDROXY-THIOBENZAMIDE 104317-54-6 C7H7NOS
Tadalafil impurity 38 Tadalafil impurity 38 185750-07-6 C14H15ClN2O3
Fulvestrant impurity H Fulvestrant impurity H
Trans-5-(Benzyloxyamino)piperidine-2-carboxylic acid,sodium salt Trans-5-(Benzyloxyamino)piperidine-2-carboxylic acid,sodium salt 2122800-38-6 C13H19N2NaO3
1-(5-(2-fluorophenyl)-1-(pyridin-2-ylsulfonyl)-1H-pyrrol-3-yl)-N- methylmethanamine fumarate 1-(5-(2-fluorophenyl)-1-(pyridin-2-ylsulfonyl)-1H-pyrrol-3-yl)-N- methylmethanamine fumarate 928615-46-7 C17H16FN3O2S
2-METHYLPYRAZINE 1,4-DIOXIDE 2-METHYLPYRAZINE 1,4-DIOXIDE 32046-26-7 C5H6N2O2
4-AMINO-1-METHYL-5-PROPYL-1H-PYRAZOLE-3-CARBOXYLIC ACID AMIDE 4-AMINO-1-METHYL-5-PROPYL-1H-PYRAZOLE-3-CARBOXYLIC ACID AMIDE 247583-78-4 C8H14N4O
Bendamustine Related Impurity 2 Bendamustine Related Impurity 2
Bendamustine Related Impurity 7 Bendamustine Related Impurity 7
Bortezomib Impurity 25 Bortezomib Impurity 25
Bortezomib Impurity 40 Bortezomib Impurity 40
Edoxaban Impurity 28 (1R,2R,4R) Edoxaban Impurity 28 (1R,2R,4R) 1255529-38-4 C21H30ClN5O5
Linagliptin Impurity 31 Linagliptin Impurity 31
Olopatadine Impurity 1 Olopatadine Impurity 1 66801-40-9 C15H10O4
Paroxetine Impurity 12 Paroxetine Impurity 12
Rivaroxaban Impurity 69 DiHCl Rivaroxaban Impurity 69 DiHCl
Sitafloxacin Impurity 5 Sitafloxacin Impurity 5 1630983-99-1 C15H12ClF4NO3
Ticagrelor Related Compound 92 Ticagrelor Related Compound 92
Valsartan Impurity 10 Valsartan Impurity 10 1314799-74-0 C23H29N5O
Vonoprazan Impurity 23 Vonoprazan Impurity 23
Adefovir Impurity 1 Adefovir Impurity 1
Bendamustine Impurity G Bendamustine Impurity G
Blonanserin Impurity K Blonanserin Impurity K
Brexpiprazole Impurity F Brexpiprazole Impurity F
Cefazolin USP Impurity D Cefazolin USP Impurity D
Cefuroxime Impurity 9 Cefuroxime Impurity 9 2165460-37-5 C8H10N2O4S
Everolimus Impurity E Everolimus Impurity E
Peramivir Impurity 3 Peramivir Impurity 3
Peramivir Impurity 8 Peramivir Impurity 8
Pitavastatin Impurity 13 Pitavastatin Impurity 13
Pramipexole Impurity R Pramipexole Impurity R
Tadalafil Impuirty 21 Tadalafil Impuirty 21
Tofacitinib Impurity 81 Tofacitinib Impurity 81
Topiroxostat Impurity 9 Topiroxostat Impurity 9 2044708-04-3 C7H10N6O
Vinorelbine EP Impurity C Vinorelbine EP Impurity C
Ethyl 4-(4-fluorophenyl)-1-methyl-2,6-dioxopiperidine-3-carboxylate Ethyl 4-(4-fluorophenyl)-1-methyl-2,6-dioxopiperidine-3-carboxylate 202534-94-9 C15H16FNO4
Tofacitinib Impurity H Tofacitinib Impurity H
3',6'-Dehydroclindamycin 3',6'-Dehydroclindamycin 1440605-51-5 C18H31ClN2O5S
Iguratimod Impurity 5 Iguratimod Impurity 5 84594-95-6 C13H11NO4
Cefradine Impurity F Cefradine Impurity F
Mirabegron Impurity Mirabegron Impurity 1684452-83-2 C26H28N6O3S2
1-methyl-1H-indol-6-ol 1-methyl-1H-indol-6-ol 130570-60-4 C9H9NO
2-(2-Hydroxyphenyl)-4-methyl-5-thiazolecarboxylic acid ethyl ester 2-(2-Hydroxyphenyl)-4-methyl-5-thiazolecarboxylic acid ethyl ester 118485-48-6 C13H13NO3S
32-Carboxycyanocobalamin 32-Carboxycyanocobalamin 121483-62-3 C63H87CoN13O15P
Alvimopan Impurity 6 Alvimopan Impurity 6
Acarbose Impurity B Acarbose Impurity B
Sofosbuvir Impurity28 Sofosbuvir Impurity28
Rivaroxaban Impurity 10 Rivaroxaban Impurity 10
Ipragliflozin Impurity 1 Ipragliflozin Impurity 1
(17α)-4-Bromo-17-hydroxy-3-oxo-19-norpregna-4,9-diene-21-nitrile (17α)-4-Bromo-17-hydroxy-3-oxo-19-norpregna-4,9-diene-21-nitrile 98149-13-4 C20H24BrNO2
316173-27-0 316173-27-0 316173-27-0 C17H28N2O5
Azilsartan Impurity Azilsartan Impurity 1821386-21-3 C22H18N4O4
Irbesartan Impurity 7 Irbesartan Impurity 7 C25H28N6O
Voriconazole Impurity 2 Voriconazole Impurity 2
Safinamide Impurity 1 Safinamide Impurity 1
Caspofungin impurit 2 Caspofungin impurit 2
Lamivudine impurity 1 Lamivudine impurity 1
Raltitrexed Impurity 1 Raltitrexed Impurity 1 1378372-01-0 C10H10N2O2
Loratadine Impurity 6 Loratadine Impurity 6 C22H23ClN2O2
Mirabegron Impurity 3 Mirabegron Impurity 3
Plerixafor Impurity C Plerixafor Impurity C
Vonoprazan Impuirty 8 Vonoprazan Impuirty 8
Sitagliptin IMpurity 4 Sitagliptin IMpurity 4
Brexpiprazole Impurity1 Brexpiprazole Impurity1
Acarbose Impurity E Acarbose Impurity E
Alvimopan Impurity 1 Alvimopan Impurity 1 2250243-53-7 C14H19NO
Febuxostat Impurity A Febuxostat Impurity A
Fingolimod Hexyl Impurity Fingolimod Hexyl Impurity 1201794-93-5 C17H29NO2
Palbociclib Impurity 1 Palbociclib Impurity 1
Trelagliptin Impurity 8 Trelagliptin Impurity 8
Bromhexine Impurity H Bromhexine Impurity H 63471-27-2 C14H21BrN2
Apixaban Impurity 17 Apixaban Impurity 17 1423803-24-0 C20H19N5O3
Rivaroxaban Impurity 11 Rivaroxaban Impurity 11 1411775-06-8 C14H17N3O4
(R)-2-(3-(diisopropylamino)-1-phenylpropyl)-4-(hydroxymethyl)phenyl propionate (R)-2-(3-(diisopropylamino)-1-phenylpropyl)-4-(hydroxymethyl)phenyl propionate C25H35NO3
Flomoxef Impurity 4 Flomoxef Impurity 4
Nicardipine Impurity 5 Nicardipine Impurity 5
11,11'-(PIPERAZINE-1,4-DIYL)-BIS-8-CHLORO-5H-DIBENZE[B,E][1,4]-DIAZEPINE 11,11'-(PIPERAZINE-1,4-DIYL)-BIS-8-CHLORO-5H-DIBENZE[B,E][1,4]-DIAZEPINE 263366-81-0 C30H24Cl2N6
Sacubitril Impurity 7 Sacubitril Impurity 7 149709-44-4 C22H25NO5
Valsartan Impurity 5 Valsartan Impurity 5 1266616-11-8 C18H21N5
3-Hydroxy Agomelatine 3-Hydroxy Agomelatine 166526-99-4 C15H17NO3
Milnacipran Impurity 4 Milnacipran Impurity 4 1353644-49-1 C15H21NO2
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