Everything you need to comply

with USP Chapter < 857 >!

High Precision in Spectro-Optics

536

640
485

TRACEABLE

Reference Materials for

UV/Vis Spectroscopy

CONTROL OF: PHOTOMETRIC LINEARITY

WAVELENGTH ACCURACY LIMIT OF STRAY LIGHT
ABSORBANCE ACCURACY RESOLUTION
 Valid from 1. December 2019

UNITED STATES PHARMACOPOEIA (USP):

USP <857> UPDATED IN DECEMBER 2019 – WHAT’S NEW?
In the years 2016 to 2019, the chapter USP <857> was
subjected to a further revision; the resulting USP <857>
(42nd edition, update from Dec. 2019) is showing the follow-
ing major changes:

The following parameters must be checked:

1 Control of wavelength accuracy: Note:

It’s not necessary to calculate the correlation coeffi-
to date: cient of the standard response to demonstrate linear-
A Holmium filter is used to check wavelength accuracy ity, just demonstrate that at the different absorbance
from 240 nm to 650 nm. levels selected the acceptance limits have been met.
A Didymium filter is used to check wavelength accuracy
above 650 nm (730 nm to 870 nm)
4 Limit of stray light:

New supplement in USP <857>
 or wavelength accuracy below 240 nm spectropho-
F
to date:
Stray light levels have to be monitored in the wave-
tometers must be checked with a Cerium filter
length range: 200 – 400 nm.
(200 nm to 255 nm)
Measuring stray light in accordance with USP <857>
requires a 5 mm reference filter and a 10 mm filter,
2 Control of absorbance accuracy:
 both filled with the same solution.

to date: New supplement in USP <857>

 V–range:
U In USP <857> (42th edition, update December 2019),
Potassium dichromate solutions are used over the
intended operational range up to 3 Abs.
Vis–range:

Neutral density glass filters are used over the intended
operational range up to 3 Abs.
New supplement in USP <857>
UV range: 0 – 1 Abs:
Potassium dichromate solutions with concentrations
from 20 – 60 mg/l, or Nicotinic acid solutions with con-
centrations from 6 – 24 mg/l may be used.
UV range: 1 – 3 Abs:
Potassium dichromate solutions with concentrations
from 80 – 200 mg/l may be used.
3 Control of photometric linearity
New supplement in USP <857>
“Verification of photometric response (linearity) is
required and it should be evaluated using a standard
type appropriate for the wavelength(s) required, where
at least three different absorbance levels appropriate
to and spanning the required operational range are
measured”
UV–range:
Nicotinic acid solutions 6 – 60 mg/l or Potassium
dichromate solutions 20 – 200 mg/l may be used.
Vis–range:

Neutral Density Glass Filters may be used.

two possible procedures are described for checking
limit of stray light.
Procedure A: the already given and discribed method.
Procedure B: The analysts can measure the stray light
filter with a path length of 10 mm against the reference
filter filled with pure water (10 mm path length), with
the exception of acetone, which is measured against
air. The measured absorbance value per filter should
be greater than 2.0 at the recommended wavelength
listed in the table:
Filter/Solution Spectral Recom-
Range (nm) mended
WL (nm)
Potassium chloride (12 g/l) 190 – 210 198
Sodium iodide (10 g/l) 210 – 270 220
Potassium iodide (10 g/l) 210 – 270 220
Acetone (pure) 250 – 330 300
Sodium nitrite (50 g/l) 300 – 400 340
5 Resolution:
 to date:
A liquid filter of Toluene in Hexane and a Hexane
reference filter are used to check the resolution of the
spectrophotometer.
 No Changes!
DOING SO ENSURES CONFORMITY WITH USP <857>
UPDATE FROM DECEMBER 2019!
Supplement your existing USP reference materials:
Please check to ensure that your reference materials comply with the updated regulations of USP <857>.

ARTICLE-NO. CONTENT WAVELENGTH nm

1   Control
 of wavelength accuracy
Filters used today
667005USP UV5: Holmium in perchloric acid 241, 250, 278, 287, 333, 345,
361, 385, 416, 452, 468, 485,
536, 640
Supplement if necessary
667035 UV35: Rare Earth (Cerium) in perchloric acid 201, 211, 222, 239, 252
667025EPUSP UV25: Didymium in perchloric acid 512, 732, 740, 794, 801, 864

2 + 3 Control of absorbance accuracy and photometric linearity

UV–range:
Filters used today
667301 UV60: Potassium dichromate 60 mg/l in perchloric acid (0.3 – 0.9 Abs) 235, 257, 313, 350
UV14: Perchloric acid (reference filter)
Supplement if necessary
Potassium dichromate filter in perchloric acid with other concentrations, 235, 257, 313, 350
from 20 to 200 mg/l (see table on page 5)
Alternative with Niacin Filters
Nicotinic acid (Niacin) filter in hydrochloric acid with concentrations, from 6 to 48 mg/l (see 213, 261
table on page 5)
Vis-range:
Filters used today
666S002 Neutral Density Glass Filters, F2 (0.25 Abs), F3 (0.5 Abs), F4 (1.0 Abs) 440, 465, 546.1, 590, 635
Supplement if necessary
Neutral Density Glass Filters with absorptions from 0.04 to 3.0 Abs (see table on page 5) 440, 465, 546.1, 590, 635

4   Control limit of stray light

Filters used to date, according to USP <857> procedure A
667100H Filter set includes 10 and 5 mm cell filled with Potassium Chloride Spectral range: 190 – 210
667101H Filter set includes 10 and 5 mm cell filled with Sodium Iodide Spectral range: 210 – 270
667119H Filter set includes 10 and 5 mm cell filled with Acetone Spectral range: 250 – 330
667102H Filter set includes 10 and 5 mm cell filled with Sodium Nitrite Spectral range: 300 – 400
Alternative according to USP <857> procedure B: Measurement against water as reference
667001 UV1, Potassium Chloride 12 g/l, ≥ 2 Abs at 198 nm Spectral range: 190 – 210
667010 UV10, Sodium Iodide 10 g/l, ≥ 2 Abs at 220 nm Spectral range: 210 – 270
667023 UV23, Potassium Iodide 10 g/l, ≥ 2 Abs at 220 nm Spectral range: 210 – 270
667019 UV19, Acetone (pure), measured against air!, ≥ 2 Abs at 300 nm Spectral range: 250 – 330
667011 UV11, Sodium Nitrite 50 g/l, ≥ 2 Abs at 340 nm Spectral range: 300 – 400
667012 UV12, Pure Water (reference filter) 198, 200, 300, 400

5   Control of resolution
Filters used today
667200 Filter set with Toluene in Hexane and Hexane reference filter Scan from 265 to 270
slit width: 0.5, 1.0, 1.5, 2.0, 3.0
No supplement necessary
BUY A NEW BASIS FILTER SET COMPLIANT
WITH NEW UPDATED USP <857>

ARTICLE-NO. CONTENT WAVELENGTH nm

667857V3 New
 Basis Filter set according to updated USP <857>
(for wavelength range 240 – 640 nm and absorbance range 0.2 – 2.0)

Control of wavelength accuracy

UV5: Holmium in perchloric acid 241, 250, 278, 287, 333, 345,
361, 385, 416, 452, 468, 485,
536, 640
Control of absorbance accuracy and photometric linearity in the UV range

!
Contains Set of Potassium dichromate filters includes: 235, 257, 313, 350
everything UV20, 20 mg/l in perchloric acid (0.1 – 0.3 Abs)
you need to UV60, 60 mg/l in perchloric acid (0.3 – 0.9 Abs)
conform with UV0140, 140 mg/l in perchloric acid (0.7 – 2.0 Abs)
USP <857>! UV14: Perchloric acid (reference filter)
(Minimum
configuration)
Control of absorbance accuracy and photometric linearity in the Vis range
Set of Neutral Density Glass filters includes: 440, 465, 546.1, 590, 635
F2 (0.25 Abs)
F4 (1.0 Abs)
F203 (2.0 Abs)
Control limit of stray light
UV19, Acetone* (pure), ≥ 2 Abs at 300 nm Spectral range: 250 – 330
Control of resolution
Filter set with Scan from 265 to 270
UV6 Toluene in Hexane, slit width: 0.5, 1.0, 1.5, 2.0, 3.0
UV9 Hexane (reference filter)
*) Measurement against air

TS
EXPER
TIP:

Birgit Kehl,
Compliance Manager
ISO / IEC 17025

“The new USP <857> opens up a wide spectrum for

checking spectrophotometers. At the Hellma Analytics
calibration laboratory, we have specially developed
UV 35, Rare Earth (Cerium) Filter reference materials to fulfill the requirements of
for testing wavelength accuracy below USP <857>.”
240 nm according to USP <857>
OVERVIEW: FILTER SETS AND FILTERS ACCORDING TO
UPDATED USP <857>

PARAMETER ARTICLE-NO. CONTENT WAVELENGTH nm

Wavelength 667035 UV35: Rare Earth (Cerium) liquid filter for testing wavelength accuracy 201, 211, 222, 239, 252
accuracy below 255 nm (according USP <857> and EP 10)
667005USP UV5: Holmium liquid filter according USP <857> 241, 250, 278, 287, 333, 345,
361, 385, 416, 452, 468, 485,
536, 640
667025EPUSP UV25: Didymium liquid filter for testing wavelength accuracy above 512, 732, 740, 794, 801, 864
640 nm (according USP <857> and EP 10)
667045EPUSP UV45, HoDi filter (Holmium and Didymium in perchloric acid) for testing 241, 287, 361, 451, 482, 512,
wavelength accuracy from 240 to 870 nm (according USP 857 and EP 10) 537, 641, 732, 740, 794, 801,
864
667425 Filter set UV 425 for testing wavelength accuracy in the range UV5: 241, 250, 278, 287, 333,
240 – 870 nm (according USP <857>), includes: 345, 361, 385, 416, 452, 468,
UV5, Holmium liquid filter and 485, 536, 640
UV25, Didymium liquid filter UV25: 732, 740, 794, 801,
864

Absorbance 667020 UV20, Potassium dichromate 20 mg/l, (0.1 – 0.3 Abs) 235, 257, 313, 350
accuracy
667040 UV40, Potassium dichromate 40 mg/l, (0.2 – 0.6 Abs) 235, 257, 313, 350
UV range
667060 UV60, Potassium dichromate 60 mg/l, (0.3 – 0.9 Abs) 235, 257, 313, 350
Potassium
667080 UV80, Potassium dichromate 80 mg/l, (0.4 – 1.2 Abs) 235, 257, 313, 350
Dichromate
6670100 UV0100, Potassium dichromate 100 mg/l, (0.5 – 1.45 Abs) 235, 257, 313, 350
6670120 UV0120, Potassium dichromate 120 mg/l, (0.6 – 1.7 Abs) 235, 257, 313, 350
6670140 UV0140, Potassium dichromate 140 mg/l, (0.7 – 2.0 Abs) 235, 257, 313, 350
6670160 UV0160, Potassium dichromate 160 mg/l, (0.8 – 2.3 Abs) 235, 257, 313, 350
6670180 UV0180, Potassium dichromate 180 mg/l, (0.9 – 2.6 Abs) 235, 257, 313, 350
6670200 UV0200, Potassium dichromate 200 mg/l, (1.0 – 3.0 Abs) 235, 257, 313, 350
667014 UV14, Perchloric acid (reference filter) 235, 257, 313, 350
667307 Linearity set UV307, includes Potassium dichromate filters with 20, 40, 235, 257, 313, 350
60, 80, 100 mg/l and reference filter

Absorbance 667506 UV506, Nicotinic acid (Niacin) 6 mg/l, 0.25 Abs) 213, 261
accuracy
667512 UV512, Nicotinic acid (Niacin) 12 mg/l, 0.5 Abs) 213, 261
UV range
667518 UV518, Nicotinic acid (Niacin) 18 mg/l, 0.75 Abs) 213, 261
Niacin
667524 UV524, Nicotinic acid (Niacin) 24 mg/l, 1.0 Abs) 213, 261
667536 UV536, Nicotinic acid (Niacin) 36 mg/l, 1.5 Abs) 213, 261
667548 UV548, Nicotinic acid (Niacin) 48 mg/l, 2.0 Abs) 213, 261
667599 UV599, Hydrochloric acid (reference filter) 213, 261
667S501 Linearity set UVS501, includes Niacin filters with 6, 12, 24 mg/l and 213, 261
reference filter
667350 Linearity set UV350, includes Niacin filters with 6, 12, 18, 24 mg/l and 213, 261
reference filter

We are happy to help.

call us +49 7631 182 1010
OVERVIEW: FILTER SETS AND FILTERS ACCORDING TO
UPDATED USP <857>

PARAMETER ARTICLE-NO. CONTENT WAVELENGTH nm

Absorbance 666F0-71 F0, Empty filter frame (reference filter)

accuracy
666F390-25 F390, Glass Filter with 0.04 Abs 440, 465, 546.1, 590, 635
Vis-range
666F2-39 F2, Neutral Density Glass Filter with 0.25 Abs 440, 465, 546.1, 590, 635
Glass Filter
666F201-39 F201, Neutral Density Glass Filter with 0.3 Abs 440, 465, 546.1, 590, 635
666F3-38 F3, Neutral Density Glass Filter with 0.5 Abs 440, 465, 546.1, 590, 635
666F204-37 F204, Neutral Density Glass Filter with 0.7 Abs 440, 465, 546.1, 590, 635
666F4-37 F4, Neutral Density Glass Filter with 1.0 Abs 440, 465, 546.1, 590, 635
666F202-36 F202, Neutral Density Glass Filter with 1.5 Abs 440, 465, 546.1, 590, 635
666F203-36 F203, Neutral Density Glass Filter with 2.0 Abs 440, 465, 546.1, 590, 635
666F301-361 F301, Neutral Density Glass Filter with 2.5 Abs 440, 465, 546.1, 590, 635
666F303-361 F303, Neutral Density Glass Filter with 3.0 Abs 440, 465, 546.1, 590, 635
666S002 Glass Filter set S002 includes 440, 465, 546.1, 590, 635
F2 (0.25 Abs), F3 (0.5 Abs) and F4 (1.0 Abs)
666S200 Glass Filter set S200 includes 440, 465, 546.1, 590, 635
F2 (0.25 Abs), F4 (1.0 Abs) and F203 (2.0 Abs)

Stray Light Limit of Stray Light according to USP <857> procedure A (Measurement with 10 mm and 5 mm cell)
667100H Set includes 10 and 5 mm cell filled with Potassium Chloride Spectral range: 190 – 210
667101H Set includes 10 and 5 mm cell filled with Sodium Iodide Spectral range: 210 – 270
667119H Set includes 10 and 5 mm cell filled with Acetone Spectral range: 250 – 330
667102H Set includes 10 and 5 mm cell filled with Sodium Nitrite Spectral range: 300 – 400
667105H Set includes 10 and 5 mm cell filled with Potassium Chloride, Sodium Spectral range: 190 – 400
Iodide, Acetone and Sodium Nitrite
Limit of Stray Light according to USP <857> procedure B (Measurement against water as reference)
667001 UV1, Potassium Chloride 12 g/l, ≥ 2 Abs at 198 nm Spectral range: 190 – 210
667010 UV10, Sodium Iodide 10 g/l, ≥ 2 Abs at 220 nm Spectral range: 210 – 270
667023 UV23, Potassium Iodide 10 g/l, ≥ 2 Abs at 220 nm Spectral range: 210 – 270
667019 UV19, Acetone* (pure), ≥ 2 Abs at 300 nm Spectral range: 250 – 330
667011 UV11, Sodium Nitrite 50 g/l, ≥ 2 Abs at 340 nm Spectral range: 300 – 400
667012 UV12, Pure Water (reference filter) 198, 200, 300, 400

Resolution 667006 UV6, Toluene in Hexane slit width: 0.5, 1.0, 1.5, 2.0, 3.0
667009 UV9, Hexane (reference filter)
667200 Filter set with Toluene in Hexane and Hexane reference filter Scan from 265 to 270
slit width: 0.5, 1.0, 1.5, 2.0, 3.0

*) Measurement against air

Hellma GmbH & Co. KG

79379 Müllheim
phone: + 49 7631 182 1010
e-mail: info.de@hellma.com
www.hellma.com

Subject to technical change!  064-510-PB05-725-EN | 07 | 2020